scholarly journals A NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF KETOROLAC TROMETHAMINE AND TRAMADOL HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORMS.

2017 ◽  
Vol 10 (5) ◽  
pp. 186
Author(s):  
Bharathi Devi Y ◽  
Sumanth Srinivas Kamatham ◽  
Bhaskara Raju V ◽  
Mohan Gandhi B ◽  
Srinivas K
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Ketorolac Tromethamine ◽  
Tramadol Hydrochloride ◽  
Relative Standard ◽  
Limit Of Quantitation

Objective: This study was embarked upon to develop a new, simple, rapid, validated reversed-phase high-performance liquid chromatography (HPLC)method for the estimation of ketorolac tromethamine (KET) and tramadol hydrochloride (TDL) in pharmaceutical dosage forms.Methods: The HPLC method was developed on Shishiedo C18 column (250 mm × 4.6 mm i.d, 5 μ) using methanol: 50 mM phosphate buffer (pH 6.0) in the ratio of 52:48 at 282 nm.Results: Retention time for the drugs was found to be 5.1 and 6.9 minutes for tramadol and ketorolac, respectively. The limit of detection for tramadoland ketorolac were found to be 1.0 and 0.1 μg/ml, limit of quantitation for tramadol and ketorolac were found to be 5.0 and 0.5 μg/ml, respectively. Linearity was established in the range of 20.0-30.0 μg/ml and 8.0-12.0 μg/ml for TDL and KET, respectively. The method was precise with % relative standard deviation <2 for both intra- and interday precision. The accuracy of the method was performed over three levels of concentration, and the recovery was in the range of 98-102%.Conclusion: From the found experimental data, it can be concluded that the developed method is accurate, precise, and selective and can be employedsuccessfully for the estimation of KET and TDL in Pharmaceutical dosage forms.Keywords: Reversed-phase high-performance liquid chromatography, Ketorolac tromethamine, Tramadol hydrochloride.

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.

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.

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.

scholarly journals A NEW REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF SERRATIOPEPTIDASE AND DICLOFENAC SODIUM IN BULK AND TABLET DOSAGE FORM

2019 ◽  
Vol 12 (1) ◽  
pp. 150
Author(s):  
Manasi Kulkarni B ◽  
Anagha Joshi M
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Diclofenac Sodium ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Tablet Dosage

Objective: The objective is to study the development of a simple, rapid, specific, precise, and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of serratiopeptidase (SER) and diclofenac (DC) sodium in bulk and tablet formulation.Methods: RP-HPLC method was developed for the simultaneous estimation of SER and DC sodium in tablet formulation. The separation was achieved by Kromasil C18 column (250 mm × 4.6 mm, 5 μm particle size) with phosphate buffer pH-7 and o-phosphoric acid:methanol:acetonitrile (5:4:1% v/v/v). Flow rate was maintained at 1 mL/min and UV detection was carried at 270 nm.Result: For RP-HPLC method, the retention time for SER and DC sodium was found to be 3.3833 min and 8.1667 min, respectively. The method was validated for accuracy, precision, and specificity. Linearity for SER and DC sodium was in the range of 5–50 μg/ml.Conclusion: The developed RP-HPLC method is simple, accurate, rapid, sensitive, precise, and economic. Hence, this method can be employed successfully for the estimation of SER and DC sodium in both bulk and tablet dosage forms.

scholarly journals A NEW REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF SERRATIOPEPTIDASE AND DICLOFENAC SODIUM IN BULK AND TABLET DOSAGE FORM

2019 ◽  
Vol 12 (1) ◽  
pp. 150
Author(s):  
Manasi Kulkarni B ◽  
Anagha Joshi M
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Diclofenac Sodium ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Tablet Dosage

Objective: The objective is to study the development of a simple, rapid, specific, precise, and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of serratiopeptidase (SER) and diclofenac (DC) sodium in bulk and tablet formulation.Methods: RP-HPLC method was developed for the simultaneous estimation of SER and DC sodium in tablet formulation. The separation was achieved by Kromasil C18 column (250 mm × 4.6 mm, 5 μm particle size) with phosphate buffer pH-7 and o-phosphoric acid:methanol:acetonitrile (5:4:1% v/v/v). Flow rate was maintained at 1 mL/min and UV detection was carried at 270 nm.Result: For RP-HPLC method, the retention time for SER and DC sodium was found to be 3.3833 min and 8.1667 min, respectively. The method was validated for accuracy, precision, and specificity. Linearity for SER and DC sodium was in the range of 5–50 μg/ml.Conclusion: The developed RP-HPLC method is simple, accurate, rapid, sensitive, precise, and economic. Hence, this method can be employed successfully for the estimation of SER and DC sodium in both bulk and tablet dosage forms.

scholarly journals A SIMULTANEOUS ESTIMATION, VALIDATION AND FORCED DEGRADATION STUDIES OF 5-FLUOROURACIL AND TEGAFUR IN A PHARMACEUTICAL DOSAGE FORM USING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD

2018 ◽  
Vol 11 (12) ◽  
pp. 132
Author(s):  
Vaishali Mistry ◽  
Akshay Yelwe ◽  
Amey Deshpande
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Stability Indicating ◽  
Rp Hplc ◽  
The Stability

Objective: The present study describes the stability indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of 5-fluorouracil and tegafur in pharmaceutical dosage forms.Method: 5-fluorouracil and tegafur the propose RP-HPLC method were developed by using Shimadzu Prominence-i LC-2030 HPLC system equipped with UV detector and chromatographic separation was carried on shim-pack gist c18 (250 × 4.6 mm, 5 μ) column at a flow rate of 1 ml/min and the run time was 10 min. The mobile phase consisted of methanol and water in the ratio of 50:50% v/v and elements were scanned using a UV detector at 271 nm.Result: The retention time of 5-fluorouracil and tegafur was found to be 2.74 and 3.66 min, respectively. A linearity response was observed in the concentration range of 13.4 μg/ml–31.3 μg/ml for 5-fluorouracil and 6 μg/ml–14 μg/ml for tegafur, respectively. Limit of detection and limit of quantification of 5-fluorouracil were 10.97 μg/ml and 33.26 μg/ml and for tegafur are 4.89 μg/ml and 14.83 μg/ml, respectively.Conclusion: The stability indicating that the method was developed by subjecting drugs to stress conditions such as acid and base hydrolysis, oxidation, photo and thermal degradation, and degraded products formed were resolved successfully from samples.

Chiral Resolution and Content Determination of Ketorolac Tromethamine Using High-performance Liquid Chromatography

2020 ◽  
Vol 17 ◽  
Author(s):  
Lei Zheng ◽  
Jing Yang ◽  
Yu-yao Guan ◽  
Lei Zhang ◽  
Chao Song ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Chiral Resolution ◽  
Ketorolac Tromethamine ◽  
Column Temperature ◽  
Relative Standard ◽  
Determination Methods

Background:: Establishing R, S-enantiomer (S-KT and R-KT) chiral resolution and determination methods for KT are of great significance. Objective:: This study aimed to establish a high-performance liquid chromatography (HPLC) method for the resolution and determination of ketorolac tromethamine (KT) enantiomers. Methods:: A CHIRALPAK AGP column (0.4  10 cm, 5 μm) was used with 10 mmol/L ammonium acetate (pH 5.5) and isopropanol (97:3) as the mobile phase. The detection wavelength was 324 nm, the flow rate was 1.0 mL/min, the column temperature was 25°C, and the injection volume was 5 μL. Results:: The resolution between S-KT and R-KT was 2.8. S-KT and R-KT demonstrated a good linear relationship in the range of 3-60 μg/mL (r > 0.999). The average recoveries of S-KT and R-KT were 99.2% and 99.8%, with relative standard deviations of 2.0% and 2.4%, respectively. Conclusion:: The established method can be used for the resolution and determination of S-KT and R-KT.

scholarly journals METHOD DEVELOPMENT AND FORCE DEGRADATION STUDIES FOR SIMULTANEOUS ESTIMATION OF SALBUTAMOL SULFATE, ETOFYLLINE AND BROMHEXINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM USING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD

2018 ◽  
Vol 11 (8) ◽  
pp. 378 ◽  
Author(s):  
Nutan Rao ◽  
Kajal D Gawde
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Salbutamol Sulfate ◽  
Uv Detector ◽  
Rp Hplc ◽  
The Stability

Objective: The present study describes the stability indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of salbutamol sulfate (SAL), etofylline (ETO), and bromhexine hydrochloride (BROM) in pharmaceutical dosage forms.Methods: The proposed RP-HPLC method was developed using Shimadzu prominence-i LC-2030 HPLC system equipped with ultraviolet (UV) detector and chromatographic separation was achieved isocratically using Shim-pack C18 (250 mm×4.6mm, 5 μ) column at a flow rate of 1 ml/min and the run time was 13 min. The mobile phase consisted of acetonitrile: 0.1M potassium dihydrogen phosphate buffer (35:65) with pH adjusted to 3.0 and eluents were scanned using UV detector at 225 nm.Result: The retention time of SAL, ETO, and BROM was found to be 2.319 min, 2.698 min, and 10.329 min, respectively. The calibration curve was linear over the concentration ranges of 1.6–3.2 μg/ml, 160–320 μg/ml, and 6.4–12.8 μg/ml for SAL, ETO, and BROM, respectively.Conclusion: The stability indicating method was developed by subjecting the drugs to stress conditions such as acid and base hydrolysis, oxidation, humidity, and photo- and thermal degradation and the degraded products formed were resolved successfully from the samples. Therefore, the proposed method can be used as a more convenient and efficient option for the simultaneous estimation of all the three drugs in bulk and combined

scholarly journals CLEANING VALIDATION OF A SIMPLE AND RAPID REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF ASPIRIN AND ROSUVASTATIN

2019 ◽  
pp. 261-265
Author(s):  
CELINA NAZARETH ◽  
GISELLE FIZARDO ◽  
CHARMAINE VAZ
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Limit Of Detection ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Cleaning Validation ◽  
Rp Hplc

Objective: This study describes a new, simple, precise, accurate, and reproducible reversed-phase high-performance liquid chromatography (RP-HPLC) cleaning validation method for simultaneous estimation of rosuvastatin and aspirin. Methods: The proposed RP-HPLC method was carried out on AGILENT-ZORBAX RP-Inertsil column (250 mm × 4.6 mm, 5 μm) in an isocratic mode utilizing potassium dihydrogen phosphate buffer (pH 2.5 with OPA):acetonitrile (50:50,v/v) as mobile phase, at a flow rate of 1.5 ml/min. Detection was carried out at 243 nm using UV detector. Results: The method was found specific as there was no swab interference. The Beer–Lambert’s law was obeyed in the concentration range of 0.5–20 μg/ml for both rosuvastatin and aspirin. The mean percentage recoveries at 100% level were 89.4% for rosuvastatin and 82.1% for aspirin. The limit of detection and limit of quantification for rosuvastatin and aspirin were 0.03 μg/ml and 0.1 μg/ml, respectively. The method was found to be robust and precise with percentage RSD <2.0%. Conclusion: A simple, novel, and economical RP-HPLC method for cleaning validation has been developed for the simultaneous estimation of rosuvastatin and aspirin. The method was validated as per ICH guidelines for specificity, linearity, accuracy, precision, and robustness. The developed method can be used as a sensitive analytical tool for ensuring the effectiveness of the cleaning procedure adopted.

scholarly journals VALIDATION OF REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS DETERMINATION OF 6-, 8-, 10-GINGEROLS AND 6-SHOGAOL FROM GINGER EXTRACTS

2020 ◽  
pp. 67-70 ◽  
Author(s):  
BENNY ANTONY ◽  
MERINA BENNY ◽  
MARY RESHMA
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Linear Calibration ◽  
Ginger Extract ◽  
Ich Guidelines ◽  
Relative Standard

Objective: Development and validation of a High-Performance Liquid Chromatography (HPLC) method for the simultaneous estimation of 6-, 8-, 10-Gingerols and 6-Shogaol in ginger extract using authentic standards. Methods: The chromatographic separation was achieved by using a C18 column and a mobile phase composed of acetonitrile, ortho-phospohoric acid in water and methanol. The proposed method was validated in terms of the analytical parameters such as specificity, accuracy, precision, linearity, range, the limit of detection (LOD) and limit of quantification (LOQ) according to ICH guidelines. Results: Linear calibration curves were obtained over concentration ranges of 10-250 µg/ml for 6-, 8-, 10-gingerols and 6-shogaol with determination coefficients more than 0.99 for each analyte. Intra and inter-day precisions of the method were found to be below 2% for each analyte, with relative standard deviation (% RSD) values in the range of 0.47 to 1.55% for 6-gingerol, 0.44 to 1.51% for 8-gingerol, 0.24 to 1.90% for 10-gingerol and 0.25 to 1.67% for 6-shogaol. The percentage recovery of gingerols and shogaol was obtained with an average of 99.53%, 99.97%, 100.13% and 100.53% respectively, which was well within acceptance range. Conclusion: Simple, accurate, precise and rapid HPLC method was developed for the simultaneous analysis of 6-, 8-, 10-gingerols and 6-shogaol and validated in accordance with ICH guidelines. The developed method was found to be suitable for the standardization of herbal extracts and polyherbal formulations for the content of 6-, 8-, 10-gingerols and 6-shogaol.

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