scholarly journals Optimasi dan Validasi Metode Kromatografi Cair Kinerja Tinggi untuk Menetapkan Kadar Asam Klorogenat dalam Ekstrak Etanol Daun Yakon (Smallanthus sonchifolius (Poepp. & Endl.) H. Robinson)

2020 ◽  
Vol 16 (1) ◽  
pp. 66
Author(s):  
Zuhelmi Aziz ◽  
Liliek Nurhidayati ◽  
Syamsudin Abdillah ◽  
Nancy Dewi Yuliana ◽  
Partomuan Simanjuntak
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Formic Acid ◽  
Chlorogenic Acid ◽  
High Performance ◽  
Biological Activities ◽  
Hplc Method ◽  
Good Precision ◽  
Smallanthus Sonchifolius ◽  
Relative Standard

<p><span id="docs-internal-guid-c5cb41fa-7fff-bcb7-a369-034e4910c35f"><span>Yakon merupakan tanaman yang dapat digunakan untuk pengobatan dan kebutuhan pangan. Salah satu kandungan zat berkhasiat dalam daun yakon adalah asam klorogenat. Asam klorogenat diketahui memiliki aktifitas sebagai antioksidan, antikanker dan antidiabetes.  Penentuan kadar asam klorogenat dalam matriks yang kompleks diperlukan metode yang selektif dengan ketelitian dan ketepatan yang baik. Pada penelitian ini dilakukan optimasi dan validasi metode kromatografi cair kinerja tinggi (KCKT) fase balik untuk penetapan kadar asam klorogenat. Ekstrak dibuat secara ultrasonikasi menggunakan pelarut etanol 95%. Kondisi optimum diperoleh menggunakan fase gerak asam format 0,1% dalam asetonitril–asam format 0,1% dalam air (gradien); fase diam oktadesilsilan (C</span><span><span>18</span></span><span>) pada suhu 30 ºC dan detektor UV pada panjang gelombang 328 nm. Metode KCKT ini memberikan hasil yang memiliki ketelitian yang tinggi dengan simpangan baku relatif 0,79% dan ketepatan yang baik dengan perolehan kembali 97,50%. Kadar asam klorogenat yang diperoleh dalam ekstrak etanol 95% daun yakon sebesar 1,02%.</span></span></p><p> </p><p dir="ltr"><span>Optimization and Validation of High Performance Liquid Chromatography Methods for Determination of Chlorogenic Acid Levels in Ethanol Extracts of Yakon Leaves (</span><span>Smallanthus sonchifolius</span><span> (Poepp. &amp; Endl.) H. Robinson). </span><span>Yacon is a plant that can be used for medication and food needs. One of the bioactive compounds of yacon leaves is chlorogenic acid. Chlorogenic acid has various biological activities, such as antioxidant, anticancer and antidiabetic activities. </span><span>To determine the chlorogenic acid in such complex matrix, such selective methods with good precision and acuracy are required.</span><span> In this study, the optimization and validation of reverse phase high performance liquid chromatography (HPLC) method for chlorogenic acid determination </span><span>were performed</span><span>. The extract was prepared by ultrasonication in 95% ethanol</span><span>.</span><span>The optimized condition for HPLC </span><span>obtained was by using</span><span> mobile phase  0.1% formic acid in acetonitrile – 0.1% formic acid in water with gradient elution, stationary phase octadesylsilane  (C</span><span><span>18</span></span><span>)  at 30 </span><span><span>o</span></span><span>C and UV detector at of 328 nm. The result showed that HPLC method had high precicion with relative standard deviation of 0.79% and high accuracy with recovery of 97.50%. The chlorogenic acid in the ethanol 95% extract of </span><span>Y</span><span>acon leaves was 1,02%.</span></p><div><span><br /></span></div>

scholarly journals Optimasi dan Validasi Metode Kromatografi Cair Kinerja Tinggi untuk Menetapkan Kadar Asam Klorogenat dalam Ekstrak Etanol Daun Yakon (Smallanthus sonchifolius (Poepp. & Endl.) H. Robinson)

2020 ◽  
Vol 16 (1) ◽  
pp. 67
Author(s):  
Zuhelmi Aziz ◽  
Liliek Nurhidayati ◽  
Syamsudin Abdillah ◽  
Nancy Dewi Yuliana ◽  
Partomuan Simanjuntak
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Formic Acid ◽  
Chlorogenic Acid ◽  
High Performance ◽  
Biological Activities ◽  
Hplc Method ◽  
Good Precision ◽  
Smallanthus Sonchifolius ◽  
Relative Standard

<p><span id="docs-internal-guid-c5cb41fa-7fff-bcb7-a369-034e4910c35f"><span>Yakon merupakan tanaman yang dapat digunakan untuk pengobatan dan kebutuhan pangan. Salah satu kandungan zat berkhasiat dalam daun yakon adalah asam klorogenat. Asam klorogenat diketahui memiliki aktifitas sebagai antioksidan, antikanker dan antidiabetes.  Penentuan kadar asam klorogenat dalam matriks yang kompleks diperlukan metode yang selektif dengan ketelitian dan ketepatan yang baik. Pada penelitian ini dilakukan optimasi dan validasi metode kromatografi cair kinerja tinggi (KCKT) fase balik untuk penetapan kadar asam klorogenat. Ekstrak dibuat secara ultrasonikasi menggunakan pelarut etanol 95%. Kondisi optimum diperoleh menggunakan fase gerak asam format 0,1% dalam asetonitril–asam format 0,1% dalam air (gradien); fase diam oktadesilsilan (C</span><span><span>18</span></span><span>) pada suhu 30 ºC dan detektor UV pada panjang gelombang 328 nm. Metode KCKT ini memberikan hasil yang memiliki ketelitian yang tinggi dengan simpangan baku relatif 0,79% dan ketepatan yang baik dengan perolehan kembali 97,50%. Kadar asam klorogenat yang diperoleh dalam ekstrak etanol 95% daun yakon sebesar 1,02%.</span></span></p><p> </p><p dir="ltr"><span>Optimization and Validation of High Performance Liquid Chromatography Methods for Determination of Chlorogenic Acid Levels in Ethanol Extracts of Yakon Leaves (</span><span>Smallanthus sonchifolius</span><span> (Poepp. &amp; Endl.) H. Robinson). </span><span>Yacon is a plant that can be used for medication and food needs. One of the bioactive compounds of yacon leaves is chlorogenic acid. Chlorogenic acid has various biological activities, such as antioxidant, anticancer and antidiabetic activities. </span><span>To determine the chlorogenic acid in such complex matrix, such selective methods with good precision and acuracy are required.</span><span> In this study, the optimization and validation of reverse phase high performance liquid chromatography (HPLC) method for chlorogenic acid determination </span><span>were performed</span><span>. The extract was prepared by ultrasonication in 95% ethanol</span><span>.</span><span>The optimized condition for HPLC </span><span>obtained was by using</span><span> mobile phase  0.1% formic acid in acetonitrile – 0.1% formic acid in water with gradient elution, stationary phase octadesylsilane  (C</span><span><span>18</span></span><span>)  at 30 </span><span><span>o</span></span><span>C and UV detector at of 328 nm. The result showed that HPLC method had high precicion with relative standard deviation of 0.79% and high accuracy with recovery of 97.50%. The chlorogenic acid in the ethanol 95% extract of </span><span>Y</span><span>acon leaves was 1,02%.</span></p><div><span><br /></span></div>

scholarly journals A Selective High-Performance Liquid Chromatography Method for the Determination of Reboxetine in Bulk Drug and Tablets

2006 ◽  
Vol 89 (6) ◽  
pp. 1552-1556
Author(s):  
ArmaĞan Önal ◽  
Olcay SaĞiri ◽  
S Müge Çetin ◽  
Sidika Toker
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Depressive Disorders ◽  
Degradation Products ◽  
Severe Depression ◽  
Hplc Method ◽  
Chromatography Method ◽  
Relative Standard

Abstract Reboxetine is used as a selective noradrenaline reuptake inhibitor for the treatment of major depressive disorders. It is effective in the treatment of severe depression and safer to use than traditional tricyclic antidepressants. In this study, a novel, simple, and rapid stability-indicating high-performance liquid chromatography (HPLC) method for reboxetine methansulfonate was successfully developed and validated for the assay of tablets. The method was used to quantify reboxetine in tablets; it employed a C18 column (150 4.6 mm id) with an isocratic mobile phase consisting of methanolphosphate buffer (pH 7, 0.02 M; 55 + 45, v/v) at a flow rate of 1.0 μmL/min. Reboxetine was detected by an ultraviolet detector at 277 nm. The retention time of reboxetine was about 4.5 min. The developed HPLC method was validated with respect to linearity, precision, sensitivity, accuracy, and selectivity. The method was linear over the concentration range 150 g/mL (r 0.9999). The limits of detection and the quantitation of reboxetine were 0.1 and 0.3 μg/mL, respectively. The relative standard deviation values for intraday and interday precision were 0.781.01 and 1.081.37%, respectively. Selectivity was validated by subjecting a stock solution of reboxetine to neutral, acid, and alkali hydrolysis, as well as oxidation, dry heat treatment, and photodegradation. The peaks of the degradation products did not interfere with the peak of reboxetine. The results indicated that the proposed method could be used in a stability assay. The proposed method was successfully applied to the determination of reboxetine in tablets. Excipients present in the tablets did not interfere with the analysis.

scholarly journals Validation of high performance liquid chromatography method for determination of meloxicam loaded PEGylated nanocapsules

2015 ◽  
Vol 51 (4) ◽  
pp. 823-832 ◽  
Author(s):  
Francine Rodrigues Ianiski ◽  
Luciane Varini Laporta ◽  
Alexandre Machado Rubim ◽  
Cristiane Luchese
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Zeta Potential ◽  
Analytical Method ◽  
High Performance ◽  
Ph Value ◽  
Hplc Method ◽  
Polydispersity Index ◽  
Size Distributions ◽  
Relative Standard

abstract A method to ensure that an analytical method will produce reliable and interpretable information about the sample must first be validated, making sure that the results can be trusted and traced. In this study, we propose to validate an analytical high performance liquid chromatography (HPLC) method for the quantitation of meloxicam loaded PEGylated nanocapsules(M-PEGNC). We performed a validation study, evaluated parameters including specificity, linearity, quantification limit, detection limit, accuracy, precision and robustness. PEGylated nanocapsules were prepared by interfacial deposition of preformed polymer, and the particle size, polydispersity index, zeta potential, pH value and encapsulation efficiency were characterized. The proposed HPLC method provides selective, linear results in the range of 1.0-40.0 μg/mL; quantification and detection limits were 1.78 μg/mL and 0.59 μg/mL, respectively; relative standard deviation for repeatability was 1.35% and intermediate precision was 0.41% and 0.61% for analyst 1 and analyst 2, respectively; accuracy between 99.23 and 101.79%; robustness between 97.13 and 98.45% for the quantification of M-PEGNC. Mean particle diameters were 261 ± 13 nm and 249 ± 20 nm, polydispersity index was 0.15 ± 0.07 and 0.17 ± 0.06, pH values were 5.0 ± 0.2 and 5.2 ± 0.1, and zeta-potential values were -37.9 ± 3.2 mV e -31.8 ± 2.8 mV for M-PEGNC and placebo(B-PEGNC), respectively. In conclusion, the proposed analytical method is suitable for the quality control of M-PEGNC. Moreover, suspensions showed monomodal size distributions and low polydispersity index indicating high homogeneity of formulations with narrow size distributions, and appropriate pH and zeta potential. The extraction process was efficient for release of meloxicam from nanostructured systems.

scholarly journals SIMULTANEOUS DETERMINATION OF DIPHENHYDRAMINE, EPHEDRINE, NOSCAPINE, AND GLYCEROL GLYCOLATE USING STABILITY-INDICATING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY: APPLICATION TO NOSCOF TABLETS

2019 ◽  
pp. 505-511
Author(s):  
PULAGURTHA BHASKARARAO ◽  
GOWRI SANKAR DANNANA
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Uv Light ◽  
Reversed Phase ◽  
Hplc Method ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Relative Standard ◽  
Validation Parameters

Objective: Noscof tablet is a fixed dosage combination formulation having diphenhydramine (DH), ephedrine (ED), noscapine (NP), and glycerol glycolate (GG). A sensitive, selective, accurate, precise, and stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method with photodiode array detection has been developed and validated for simultaneous analysis of DH, ED, NP, and GG in bulk drug and Noscof tablets. Methods: Reversed-phase chromatographic separation and analysis of DH, ED, NP, and GG were done on an Altima C18 column with 0.01 M KH2PO4 buffer (pH 3.5) and acetonitrile (50:50%, v/v) as mobile phase at 0.8 ml/min flow rate in isocratic mode. Detection was performed at 260 nm. The method was validated in harmony with International Conference on Harmonization (ICH) guidelines. The tablet sample solution was subjected to diverse stress conditions using ICH strategy such as hydrolytic degradation (neutral - with distilled water, alkaline - with 2 N NaOH, and acidic - with 2 N HCl), oxidation (with 10% H2O2), photodegradation (exposing to UV light), and dry heat degradation (exposing to 105°C). Results: Using the above stated chromatographic conditions, sharp peaks were obtained for ED, NP, DH, and GG with retention time of 3.272 min, 4.098 min, 5.467 min, and 6.783 min, respectively. Good regression coefficient values were obtained in the range of 2–12 μg/ml for ED, 3.75–22.5 μg/ml for NP, 3.125–18.75 μg/ml for DH, and 25–150 μg/ml for GG. The quantification limits were 0.181 μg/ml, 0.187 μg/ml, 0.246 μg/ml, and 1.114 μg/ml for ED, NP, DH, and GG, respectively. The values of validation parameters are within the acceptance limits given by ICH. The ED, NP, DH, and GG showed more percent of degradation in acid condition and less percent of degradation in the neutral condition. The peaks of degradants did not interfere with the peaks of analytes. ED, NP, DH, and GG were assessed with a good percentage of the assay (near to 100%) and low percent relative standard deviation (<2%) in Noscof tablets using the proposed method. Conclusion: The stability indicating RP-HPLC method developed was suitable for quantifying ED, NP, DH, and GG simultaneously in bulk as well as in tablet formulation.

Validation of HPLC Method for Determination of Histamine in Human Immunoglobulin Formulations

2020 ◽  
Vol 103 (5) ◽  
pp. 1223-1229
Author(s):  
Michikazu Tanio ◽  
Toru Nakamura ◽  
Hideki Kusunoki ◽  
Kyohei Ideguchi ◽  
Kazuyuki Nakashima ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Standard Deviation ◽  
High Performance ◽  
Gradient Elution ◽  
Hplc Method ◽  
Human Immunoglobulin ◽  
Histamine Dihydrochloride ◽  
Relative Standard

Abstract Background Histamine fixed-immunoglobulin formulations, which consisted of 0.15 µg of histamine dihydrochloride and 12 mg of human immunoglobulin in a vial, are used for anti-allergic treatments, and controlling the amounts of histamine in the formulations is essential to avoid histamine intoxication. Objective A high-performance liquid chromatography (HPLC) method for determination of histamine contents of the formulations was established and validated. Methods Histamine extracted from the formulation was labeled with 6-aminoquinolyl-N-hydroxysuccinimidyl carbamate and was analyzed by gradient elution HPLC with UV detection at 260 nm. Results The method showed linearity in the range 0.8–2.4 µM (R &gt; 0.999), accuracy (100.1–105.8% recovery), and precision (relative standard deviation ≤ 1.93%). The validated method was applied for five lots of the pharmaceutical, and their histamine contents were determined to be 0.149–0.155 µg/vial. Conclusions These results indicated that the validated method is useful to control amounts of histamine in biopharmaceutical products. Highlights The HPLC method was developed for quantitative determination of histamine content of the histamine fixed-immunoglobulin formulations.

scholarly journals A NEW HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SEPARATION AND SIMULTANEOUS QUANTIFICATION OF EPTIFIBATIDE AND ITS IMPURITIES IN PHARMACEUTICAL INJECTION FORMULATION

2021 ◽  
pp. 165-172
Author(s):  
K. SRI GIRIJA ◽  
BIKSHAL BABU KASIMALA ◽  
VENKATESWARA RAO ANNA
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Degradation Products ◽  
Ultra Violet ◽  
Hplc Method ◽  
Chromatography Method ◽  
Standard Drug ◽  
Pharmaceutical Dosage Forms ◽  
Relative Standard

Objective: The objective of the present study is to develop a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for qualitative and quantitative determination of Eptifibatide and its impurities in bulk and pharmaceutical dosage forms. Methods: The chromatographic separation was carried on Phenomenex Luna C18 column (250 mm×4.6 mm; 5µ id) as stationary phase, methanol and phosphate buffer at pH 6.4 in the ratio of 65:45 (v/v) as mobile phase at flow rate of 1.0 ml/min, Ultra Violet (UV) detection was carried at the wavelength of 236 nm and the analysis was completed with a run time of 15 min. Results: In the developed conditions, the retention time of Eptifibatide and its impurities 1 and 2 were found to be 3.35, 4.93 and 8.18 min, respectively. The method was validated for system suitability, range of analysis, precision, specificity, stability and robustness. Spiked recovery at 50%, 100% and 150% was carried for both standard and impurities and the acceptable % recovery of 98-102 was observed for Eptifibatide and both impurities studied and the % Relative standard deviation (RSD) in each spiked level was found to be less than 2. Stability tests were done through the exposure of the analyte solution to five different stress conditions i. e expose to 1N Hydrochloric acid (HCl), 1 N Sodium hydroxide (NaOH), 3% Hydrogen peroxide (H2O2), 80 °C temperature to UV radiation. In all the degradation conditions, standard drug Eptifibatide was detected along with both the impurities studied and the degradation products were successfully separated. In the formulation analysis, there is no other chromatographic detection of other impurities and formulation excipients. Conclusion: The developed method was found to be suitable for the quantification of Eptifibatide and can separate and analyse impurities 1 and 2.

scholarly journals Chemical Constituents of Snake Fruit (Salacca zalacca (Gaert.) Voss) Peel and in silico Anti-aging Analysis

2019 ◽  
Vol 3 (2) ◽  
pp. 122
Author(s):  
Ermi Girsang ◽  
I Nyoman Ehrich Lister ◽  
Chrismis Novalinda Ginting ◽  
Adrian Khu ◽  
Butter Samin ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Chlorogenic Acid ◽  
High Performance ◽  
Biological Activities ◽  
Chemical Constituents ◽  
Palm Tree ◽  
Triterpenoid Saponin ◽  
Fruit Peel ◽  
Wide Range

Background: Skin aging is a condition where skin is unable to retain both its physiological and structural integrity. Plants is the main source of phtytochemicals compound with wide range of biological activities. Through the efforts of ongoing scientific researches, an increasing number of plant extracts and phytochemicals have been showed promising result as anti-aging agent. Snake fruit (Salacca zalacca (Gaert.) Voss) is tropical plant belongs to the palm tree family (Arecaceae) that served as important crop in Indonesia. Despite its utilization, the phytochemical compound available in snake fruit, especially its peel have not been well documented. Present study aimed to elucidate the phytochemical constituent of snake fruit peel and its anti-aging potency.Materials and Methods: Snake fruit peel extract (SPE) was subjected to qualitative phytochemical assay, high performance liquid chromatography, and molecular docking towards protein related in skin aging.Results: The screening showed SPE contained phytochemical compound belong to flavonoid, tannin, phenol, triterpenoid, saponin and alkaloid. Thus, based on the analysis only chlorogenic acid was present in SPE whilst rutin and caffeic acid were not detected. The SPE was contained chlorogenic acid around 1.074 mg/g dry weight. Chlorogenic acid had the high binding affinity towards matrix metalloproteinase (MMP)-1 (-9.4 kcal/mol).Conclusion: Current findings may provide scientific evidence for possible usage of SPE and its compounds as antioxidant and anti-aging agent.Keywords: Salacca zalacca, phytochemical compound, high performance liquid chromatography, anti-aging

Development and Validation of a High-Performance Liquid Chromatography Method for Standardization of the Bioactive Ethyl Acetate Fraction of Alstonia scholaris (Linn.) R. Br. Growing in Egypt

2013 ◽  
Vol 68 (9-10) ◽  
pp. 376-383
Author(s):  
Hesham I. El-Askary ◽  
Mahmoud M. El-Olemy ◽  
Maha M. Salama ◽  
Mahetab H. Amer
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Ethyl Acetate ◽  
High Performance ◽  
Ethanolic Extract ◽  
Ethyl Acetate Fraction ◽  
Hplc Method ◽  
Spectroscopic Techniques ◽  
Alstonia Scholaris ◽  
Relative Standard

Bio-guided fractionation of the ethanolic extract of the leaves of Alstonia scholaris (Apocynaceae) growing in Egypt was carried out to evaluate its antihyperglycemic acti vity in alloxan-induced diabetic rats and its hepatoprotective activity against CCl4-induced hepatotoxicity in rats. The ethyl acetate fraction of the ethanolic extract showed the highest antihyperglycemic [(133.6 ± 4.2) mg/mL, relative to metformin with (92.3 ± 2.7) mg/mL] and hepatoprotective [(37.9 ± 1.4) U/L, relative to silymarin with (29.7 ± 0.8) U/L] activities. Four compounds were isolated from this fraction, and identifi ed by spectroscopic techniques and by comparison with reported data: caffeic acid and isoquercitrin for the fi rst time from this plant, in addition to quercetin 3-O-β-D-xylopyranosyl (1''' →2")-β-D-galactopyranoside (major compound) and chlorogenic acid. A validated reversed phase-high-performance liquid chromatography (RP-HPLC) method was developed for the standardization of the bio active ethyl acetate fraction. The calibration curve showed good linearity (r2 > 0.999) within tested ranges. The relative standard deviation of the method was less than 3% for intra- (0.4 - 2.0%) and inter-day (1.9 - 2.8%) assays. Mean recovery of the method was within the range of 98.5 - 102.5%. The minimum detectable concentration of the analyte (LOD) was found to be 0.04 μg/mL. This developed HPLC method was shown to be simple, rapid, precise, reproducible, robust, specifi c, and accurate for quality assessment of the bioactive fraction

scholarly journals HPLC method for analysis of substrate and products in beverage alcohol production

1969 ◽  
Vol 74 (4) ◽  
pp. 357-364
Author(s):  
Eduardo Rosado ◽  
Heriberto Batiz ◽  
Mercedes Vilella
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Standard Deviation ◽  
Relative Standard Deviation ◽  
High Performance ◽  
Hplc Method ◽  
Alcohol Production ◽  
Relative Standard

A procedure was developed and validated for the determination of sugars by high performance liquid chromatography (HPLC). The system studied consisted of a Sugar-pak column operated continuously and with a methanol flow when not in use, as opposed to manufacturer's instructions, which recommend refrigeration of the column during the weekends when idle. This column is recommended for analysis of sugar products and process streams such as those of beet and sugarcane. Evaluations of this technique included a range of samples and procedure variables necessary to validate the effectiveness of the column. An excellent resolution and reproducibility was obtained among the sucrose, glucose, fructose and ethanol signals. The precision was within the accepted limits of less than 2% relative standard deviation.

scholarly journals DEVELOPMENT AND VALIDATION OF NEW STABILITY INDICATING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE AND ERTUGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

2019 ◽  
Vol 12 (1) ◽  
pp. 235
Author(s):  
Venkateswara Rao P ◽  
Lakshmana Rao A ◽  
Prasad Svum
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Hplc Method ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Relative Standard ◽  
Validation Parameters

Objective: The present study deals with the development, validation, and application of simple, precise, and accurate high-performance liquid chromatography (HPLC) method for the simultaneous estimation of metformin hydrochloride and ertugliflozin in pharmaceutical formulation and to validate.Methods: The analytical conditions were optimized on BDS C8 column (150 mm × 4.6 mm, 5 μm) at room temperature. The mobile phase consists of buffer: acetonitrile in 55:45 v/v ratio. Injection volume was 10 μl. The flow rate was maintained at 1.0 ml/min, and the analysis was carried out at 224 nm.Results: The method was found to be linear in the concentration range of 125–750 μg/ml and 1.875–11.25 μg/ml for metformin hydrochloride and ertugliflozin with regression coefficient r2 = 0.999. The method was found to be precise with percentage relative standard deviation below 2%. The limit of detection and limit of quantification were found to be within the limits. The percentage recovery of the developed method was 100.15%. All the validation parameters such as robustness, recovery, and precision were found to be within the limits. Degradation parameters such as acid, base, thermal and peroxide, light, temperature, and humidity were performed and found that the drugs are stable in all the extreme conditions.Conclusions: A simple, accurate, precise, and less time-consuming reversed-phase HPLC method for the simultaneous estimation of metformin hydrochloride and ertugliflozin has been developed and validated in accordance with the ICH guidelines.

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