scholarly journals STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ROSUVASTATIN CALCIUM IN BULK AND TABLET FORMULATION BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2019 ◽  
pp. 251-256
Author(s):  
SAILAJA B ◽  
SRAVANA KUMARI K
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Reverse Phase ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Development And Validation ◽  
Rosuvastatin Calcium

Objective: The present work was focused on the development and validation of reverse-phase high-performance liquid chromatography (RP-HPLC) method which is simple, rapid, precise, accurate, sensitive, economical, and stability indicating for the quantitation of rosuvastatin calcium in bulk and tablet formulation. Methods: The separation was attained on Waters Symmetry C18 column with dimensions 150×4.6 mm, 5 mm particle size employing 0.1% orthophosphoric acid buffer:acetonitrile in the ratio of 55:45% v/v as mobile phase, which was pumped at a rate of 1.0 ml/min and detected at a wavelength of 241 nm. Results: The linearity of the method was demonstrated in the concentration range of 2–12 μg/ml for rosuvastatin calcium with a correlation coefficient (r2) of 0.999, percentage drug recovery was found to be 100.22–101.16%, and percentage relative standard deviation <2. Limit of detection and limit of quantitation values were found to be 0.013 μg/ml and 0.042 μg/ml, respectively, and assay of marketed tablet formulation was found to be 99.76%. Conclusion: The developed RP-HPLC method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical and could be used for regular quality control of rosuvastatin calcium in bulk and tablet formulation.

scholarly journals STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND CLOPIDOGREL BISULFATE IN PHARMACEUTICAL DOSAGE FORM BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2020 ◽  
pp. 84-90
Author(s):  
AWDHUT PIMPALE ◽  
RAJENDRA KAKDE
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Clopidogrel Bisulfate ◽  
Rp Hplc ◽  
Development And Validation

Objective: The present work was focused on the development and validation of reversed-phase high-performance liquid chromatography (RP-HPLC) method which is simple, rapid, precise, accurate, sensitive, economical, and stability-indicating for the quantification of rosuvastatin (RSV) calcium and clopidogrel bisulfate (CLO) in bulk and tablet formulation. Methods: The separation was attained on RP Princeton (C18) column with dimensions (250 mm × 4.6 mm, 5 μ) employing buffer which is a mixture of water (pH 3.0, adjusted with orthophosphoric acid), and methanol in the ratio (20:80) v/v as mobile phase, at flow rate 1.0 ml/min and detection was carried out at wavelength 240 nm. The retention time under the optimized condition of RSV calcium and CLO was found to be 2.844 min and 4.388 min, respectively. Results: The linearity of the method was demonstrated in the concentration range of 6–16 µg/ml and 45–120 µg/ml for RSV calcium and CLO with a correlation coefficient (r2) of 0.9999 and 0.9996, respectively. The percentage relative standard deviation was ˂2% and percentage recovery was found to be 100.12–101.37% and 99.72–101.09% for RSV calcium and CLO, respectively. Assay of marketed tablet formulation was found to be 98.99% and 99.92%, respectively. Conclusion: The developed RP-HPLC method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical and could be used for regular quality control of RSV calcium and CLO in bulk and tablet formulations.

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE ESTIMATION OF LEDIPASVIR IN BULK AND TABLET DOSAGE FORM

2019 ◽  
pp. 326-331
Author(s):  
MINAL R GHANTE ◽  
SANJAY D SAWANT ◽  
AMOLDEEP SHINDE ◽  
SHITAL GODSE ◽  
VANDANA S NIKAM
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Reverse Phase ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Tablet Dosage

Objective: The objective of this study was to develop a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the estimation of ledipasvir (LDP) in bulk and tablet formulation. Methods: Stability-indicating RP-HPLC method was developed and validated for the estimation of LDP in bulk and tablet formulation. RP-HPLC was carried out on HiQ SiL C18 columns (250 mm × 4.6 mm, 5 μ particle size) using mobile phase acetonitrile:1 mM ammonium acetate buffer in the ratio of 90:10 v/v at a flow rate of 1 ml/min. The analytes were monitored using MD 2010 PDA detector at 333 nm. Results: The retention time was found to be 3.843 min. The proposed method was found to be having linearity in the concentration range of 5–30 μg/ml. The number of theoretical plates obtained was 4236.50 which indicate the efficient performance of the column. The limit of detection was 0.305 μg/ml and limit of quantification was 0.923 μg/ml, which indicate the sensitivity of the method; the high percentage recovery indicates that the proposed method is highly accurate. The developed method has been validated according to the ICH guidelines and found to be simple, specific, precise, and accurate. Conclusion: The proposed method is precise, accurate, and stability indicating. Therefore, the proposed method can be used for routine quality control and analysis of LDP during stability studies in bulk samples and tablet dosage forms.

scholarly journals STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ROSUVASTATIN CALCIUM IN PHARMACEUTICAL DOSAGE FORM BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

2020 ◽  
pp. 9-16
Author(s):  
AWDHUT PIMPALE ◽  
RAJENDRA KAKDE
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Relative Standard ◽  
Tablet Formulations ◽  
Development And Validation ◽  
Rosuvastatin Calcium

Objective: The present work was focused on the development and validation of the reversed-phase high-performance liquid chromatography (RP-HPLC) method, which is simple, rapid, precise, accurate, sensitive, economical, and stability-indicating for the quantification of rosuvastatin calcium in bulk and tablet formulation. Methods: The separation was attained on reversed-phase Princeton (C18) column with dimensions (250 mm × 4.6 mm, 5μ) employing buffer, which is a mixture of water (pH 3.0, adjusted with orthophosphoric acid) and methanol in the ratio (20:80) v/v as mobile phase, at flow rate 1.0 ml/min. and detection was carried out at wavelength 240 nm. The retention time under the optimized condition of rosuvastatin calcium was found to be 2.844 min. Results: The linearity of the method was demonstrated in the concentration range of 6-16 µg/ml for rosuvastatin calcium with a correlation coefficient (r2) of 0.9999. The percentage relative standard deviation was ˂2% and percentage recovery was found to be 100.12-101.37% for rosuvastatin calcium. The assay of marketed tablet formulations was found to be 98.99%. Conclusion: The developed RP-HPLC technique was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical and will be used for regular quality control of rosuvastatin calcium in bulk and tablet formulations.

scholarly journals Reverse-phase High-Performance Liquid Chromatography Method Development and Validation for Estimation of Glimepiride in Bulk and Tablet Dosage Form

2020 ◽  
Vol 11 (02) ◽  
pp. 296-302
Author(s):  
Aseem Kumar ◽  
Anil Kumar Sharma ◽  
Rohit Dutt
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
High Performance ◽  
Hplc Method ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Development And Validation

The present work demonstrates a simple, rapid, precise, specific, and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method for analyzing glimepiride in pure and tablet forms. The present method was developed using a C18 column 150 × 4.6 mm, with 5 μm, and packing L1 maintained at a temperature of 30°C. The mobile phase was prepared by dissolving 0.5 gram of monobasic sodium phosphate in 500 mL of distilled water, pH of the solution adjusted to 2.1 to 2.7 with 10% phosphoric acid, and added 500 mL of acetonitrile. The mobile phase was pumped in the highperformance liquid chromatography (HPLC) system at a flow rate of 1 mL/min, and separation was carried out at 228 nm, using an ultraviolet (UV) detector. The chromatographic separation was achieved with peak retention time (RT) at about 9.30 minutes, and the method was found to be linear over a concentration range of 40 to 140 μg/mL. The specificity of the method represented no interference of the excipients during the analysis, and stability testing after 24 hours also showed that the method is suitable and specific. The accuracy was between 99.93 to 99.96%, with limit of detection (LOD) and limit of quantitation (LOQ) being 0.354 μg/mL, 1.18 μg/mL, respectively. Satisfactory results were found for precision and robustness parameters during the development and validation stage for the analytical method. The proposed method was also adopted for the analysis of glimepiride tablets to improve the overall quality control. Using this method, symmetric peak shape was obtained with reasonable retention time. The retention time of glimepiride for six repetitions is 9.3 ± 0.1 minutes; the run time is 21 minutes. The proposed RP-HPLC method is a modification of the United States Pharmacopeia (USP) method, and it was found to be valid for glimepiride within concentration ranges 40 to 140 μg/mL, using C18 analytical columns, and isocratic elution with UV detection, and at 1 mL/min of flow rate.

scholarly journals VALIDATED AND QUANTIFIED STABILITY INDICATING STRESS DEGRADATION STUDY OF ORAL ANTI-DIABETIC AGENT CANAGLIFLOZIN BY RP-HPLC METHOD

2021 ◽  
pp. 358-363
Author(s):  
ARULSELVAN MURUGESAN ◽  
MUKTHINUTHALAPATI MATHRUSRI ANNAPURNA
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Stress Degradation

Objective: The present investigation is aimed to develop and validate, a simple, consistent and sensitive stability-indicating reverse phase-high performance liquid chromatography (RP-HPLC) method for the determination of oral anti-diabetic drug Canagliflozin in bulk and pharmaceutical dosage form as per the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH-Q2 (R1)). Methods: The chromatographic separation was achieved by using Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) ZORBAX C18 (250 mm x 4.6 mm, 5μm particle size) with a mobile phase consisting of Acetonitrile: Water in a ratio of 53:47% v/v at a flow rate of 1 ml/min with an injection volume of 20 μl. Results: The Retention time of the drug Canagliflozin was found to be 2.36±0.05 min and detected at 214 nm UV wavelength. The linear regression equation was found to be y = 60702x–2156.2 with a correlation coefficient 0.9999. Stress degradation studies were performed by exposing the Canagliflozin into acidic, alkaline, oxidative, thermal and photolytic stress conditions with active samples withdrawn at different time intervals as per ICH guidelines. Conclusion: The proposed Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was found to be robust, precise and specific for estimation of Canagliflozin in pharmaceutical dosage forms.

scholarly journals STABILITY INDICATING REVERSE-PHASE HIGH- PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN AND BENIDIPINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

2018 ◽  
Vol 11 (5) ◽  
pp. 342
Author(s):  
Majan Naim ◽  
Aejaz Ahmed ◽  
Khan Gj
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Reverse Phase ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Development And Validation

 Objective: Development and validation of stability indicating reverse-phase high- performance liquid chromatography (RP-HPLC) method for simultaneous estimation of telmisartan (TEL) and benidipine hydrochloride (BND) in pharmaceutical dosage form.Methods: Reverse phase chromatography was selected because of its suggested use for ionic and moderate to non-polar compounds. Reverse phase chromatography is simple, suitable, better regarding efficiency, stability, and reproducibility. C18 column, a 250×4.6 mm column of 5.0 μm particle packing, was selected for separation of TEL and BND. Different solvent systems were tried and optimized in combinations as mobile phase. TEL (40 μg/ml) and BND (4 μg/ml) in buffer, pH 4.0: Methanol (50:50) was developed as it was showing good peak shapes and a significant amount of resolution. The mobile phase was flowed at 1.0 ml/min with detection of both the analytes at 210 nm using photodiode array detector.Result: Development of method was done, and validation was accomplished using specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantitation. The method was found linear from 20 to 60 μg/ml and 2–6 μg/ml for TEL and BND individually. The percentage recoveries of TEL 100.46% and BND100.08% were, respectively.Conclusion: This stability indicating RP-HPLC methods were developed by degradation of sample and compared with standard. The percentage relative standard deviation was also <2 % showing high degree of precision of the proposed method. The proposed method can be used for routine analysis of benidipine HCl and TEL in combined dosage form and quality control in bulk manufacturing.

Development and Validation of a RP-HPLC Method for the Simultaneous Determination of LevamisoleHCl and Oxyclozanideand its Application in the Assay of Veterinary Bolus Formulations

2020 ◽  
Vol 16 ◽  
Author(s):  
Kemal Hussien Seid ◽  
Tarekegn Berhanu ◽  
Kaleab Asres ◽  
Ayenew Ashenef
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Correlation Coefficients ◽  
Hplc Method ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Average Accuracy ◽  
Development And Validation

Introduction: A reverse-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous analysis of two drugs, levamisole hydrochloride(LH) and oxyclozanide(OX), in co-formulations for veterinary use. Materials and Methods: The new HPLC method was validated per ICH and other guidelines. A C18 column was used with agradient program; eluent A was an equal mixture of methanol and acetonitrile, and eluent B a 25 mM phosphate buffer at pH 7.0 containing 30 mM sodium decanesulfonate andtriethylamine(50:50:1 v/v)then pH adjusted to 7.0 with H3PO4 [51:49 v/v] .The detection wavelength was set at 220 nm.For the final gradient program, the retention times were 8.2(for LH)and 13.6(for OX) minutes respectively at flow rate of 1 ml/min over 20 minute run time. Results: The method wasprecise, specific and robust.The correlation coefficients, R2 were 0.9998 and 0.9999 for LH and OX respectively in the ranges of 5 – 280 µg / mL.The percent y-intercepts and percent residual standard deviations were 1.6%/0.4% and 1.4%/1.0% for LH and OX, respectively. The LOD and LOQ of the method were 0.21 µg / mL and 0.62 µg / mL for LHand 0.06 µg / mL and 0.18 µg / mL for OX. The method has average accuracy of 100.5% for LH and 101.1% for OX when tested on veterinary bolus formulations, and the samples couldbe stored under typical lab conditions for about 7 days without significant degradation. Conclusion: This HPLC method is suitable forassayinglevamisole hydrochloride and oxyclozanide simultaneously from veterinary formulations.

Development of reverse phase-high performance liquid chromatography (RP-HPLC) method for determination of selected antihypertensive active flavonoids (rutin, myricetin, quercetin, and kaempferol) in medicinal plants found in Botswana

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Katso Binang ◽  
David T. Takuwa
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Medicinal Plants ◽  
High Performance ◽  
Zingiber Officinale ◽  
Hplc Method ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Lippia Javanica

Abstract The aim of the study was to develop a rapid, efficient, and cheap chromatographic method for determining four selected antihypertensive active flavonoid compounds in medicinal plants in Botswana. The determination of rutin, quercetin, and kaempferol in selected medicinal plants was conducted in less than 6 min using the developed reverse phase-high performance liquid chromatography (RP-HPLC) method with a 2.7 µm Ascentis C18 express column (150 × 4.60 mm i.d) at 340, 360, and 368 nm detection wavelengths and mobile phase of methanol and 0.068% of formic acid solution in isocratic elution. Validation results showed good selectivity, linearity (r 2 > 0.99), high percentage recoveries (90.2–104.7%), and precision (% RSD < 2) for n = 3, confirming suitability of the method for determination of the investigated flavonoids in Zingiber officinale (ginger). Application of the developed RP-HPLC method was performed in selected medicinal plants (Lippia javanica ) (mosukujane), Myrothanmus flabellious (galalatshwene), and Elephantorrhiza elephantina (mositsana) used to manage hypertension by herbalists in Botswana. M. flabellious a very commonly used plant for managing hypertension was found to contain highest amounts of rutin and myricetin, whereas nothing was detected for E. elephantina.

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.

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