Development and validation of a stability-indicating RP-HPLC method for simultaneous determination of dapagliflozin and saxagliptin in fixed-dose combination

2018 ◽  
Vol 42 (4) ◽  
pp. 2459-2466 ◽  
Author(s):  
N. Singh ◽  
P. Bansal ◽  
M. Maithani ◽  
Y. Chauhan
Keyword(s):  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Dose Combination ◽  
Development And Validation ◽  
Tablet Dosage

A simple and precise stability indicating method for the simultaneous estimation of dapagliflozin and saxagliptin in combined tablet dosage form was developed and validated using RP-HPLC.

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF BERBERINE AND CURCUMIN IN AN AYURVEDIC FORMULATION

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (08) ◽  
pp. 48-52
Author(s):  
K. P Parekh ◽  
◽  
A. P. Jadhav
Keyword(s):  
Mobile Phase ◽  
Herbal Medicines ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Quality And Safety ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Water Ph ◽  
Development And Validation

A simple, accurate, precise, robust stability indicating RP-HPLC method was developed and validated for simultaneous estimation of berberine and curcumin in an ayurvedic formulation. The two markers were resolved using a C-18 column using as the mobile phase methanol: water (pH 3 adjusted using acetic acid) in the ratio 75:25 V/V at a flow rate of 1mL/min. Retention times of berberine and curcumin were 2.58 ± 0.2 min and 8.5 ± 0.2 min, respectively at 358 nm. Linear response was observed in the concentration range of 2 – 8 ppm for berberine and 5 – 40 ppm for curcumin, with correlation coefficient (r2) of 0.994 and 0.998 for berberine and curcumin, respectively. The developed method was applied for quantitation of markers in marketed and in-house formulations of Gruhadhoomadi Churna. This method can also be used to evaluate formulations containing berberine and curcumin as markers, thus conforming to the need of ensuring quality and safety of herbal medicines.

scholarly journals Simultaneous estimation of Curcumin and Gefitinib in bulk by using RP-HPLC technique with PDA detector

2018 ◽  
Vol 10 (1) ◽  
pp. 1-8
Author(s):  
Sagar Kishor Savale
Keyword(s):  
Chromatographic Method ◽  
Method Development ◽  
Estimation Method ◽  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Dose Combination ◽  
Hplc Method Development ◽  
Development And Validation

Plan: RP-HPLC method development and validation for the simultaneous estimation of curcumin and Gefitinib in bulk. Preface: RP-HPLC chromatographic method the been widely employed in the determination of individual components in a mixture or fixed dose combination. For the ternary mixture containing Curcumin and Gefitinib, no chromatographic method for simultaneous evaluation has been reported so far. Thus our aim is to develop a simultaneous estimation method for curcumin and gefitinib by using an RP-HPLC method using a PDA detector. Methodology: The method was validated as per ICH guidelines. The recovery studies confirmed the accuracy and precision of the method. Outcome: The proposed method was found to be accurate, repeatability and consistent. It was successfully applied for the analysis of the drug in the marketed formulation and could be effectively used for the routine analysis of formulation containing the drug without any alteration in the chromatography conditions.

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD RP-HPLC METHOD OF ACOTIAMIDE

2018 ◽  
Vol 10 (9) ◽  
pp. 1 ◽  
Author(s):  
Charu P. Pandya ◽  
Sadhana J. Rajput
Keyword(s):  
Limit Of Detection ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Acid And Base ◽  
Stress Degradation ◽  
Development And Validation ◽  
Tablet Dosage

Objective: The objective of present work was to develop and validate simple, precise, accurate and specific stability indicating method for determination of acotiamide in presence of its degradation products.Methods: An isocratic RP-HPLC method has been developed using C-8 Thermo Hypersil BDS Column (250 x 4.6 mm i.d., 5µparticle size) with the mobile phase composition of acetonitrile: 0.1 % triethylamine in 0.2% formic acid (30: 70) at column oven temperature of 40 °C. The flow rate was 1.0 ml min-1 and effluent was detected at 282 nm. The method was validated in terms of linearity, accuracy, precision, LOD (Limit of Detection), LOQ (Limit of Quantification) and robustness as per ICH guidelines.Results: The method was found to be linear in the range of 10-60µg/ml. Limit of detection and limit of quantification was found to 0.36µg/ml and 1.10 µg/ml.% Recovery was found to be in the range of 99.45%-99.75%and precision less than 2%. The developed method was successfully applied for estimation of Acotiamide in marketed tablet formulation and percentage assay was found to be 100.45%. Acotiamide was subjected to stress degradation under acid, base, neutral hydrolysis, oxidation, dry heat, photolysis conditions. Significant degradation was observed in acid and base degradation.Conclusion: The developed RP-HPLC method was simple, rapid, accurate, precise and stability indicating for the estimation of Acotiamide in bulk and tablet dosage form.

scholarly journals Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Sofosbuvir, Velpatasvir, and Voxilaprevir in Tablet Formulation

2020 ◽  
pp. 7-14
Author(s):  
Deepthi R ◽  
Gowri Sankar D
Keyword(s):  
High Performance ◽  
Hplc Method ◽  
Solution Stability ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Optimized Conditions

Objective: The present study aimed to develop a stability-indicating reverse-phase high performance-liquid chromatography (RP-HPLC) method for the estimation of Sofosbuvir, Velpatasvir, and Voxilaprevir in tablet dosage form and validated in accordance with ICH guidelines. Methods: The optimized conditions for the developed RP-HPLC method are Agilent C18 (250 mm×4.6mm, 5μ) column maintained at 30ºC with a mobile phase consisting of Buffer(0.1%OPA) and Acetonitrile taken in the ratio 55:45%v/v on isocratic mode at flow rate 1.0ml/min. The sample was detected at 220 nm. Results: The retention time of Sofosbuvir, Velpatasvir, and Voxilaprevir was found to be 2.17, 2.731 and 3.55 min respectively. The developed method was validated for accuracy, precision, specificity, ruggedness, robustness and solution stability.

DEVELOPMENT AND VALIDATION OF NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ELBASVIR AND GRAZOPREVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2020 ◽  
Vol 57 (09) ◽  
pp. 53-59
Author(s):  
Girija Dandu ◽  
Basu Venkateswara Reddy
Keyword(s):  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Hplc Grade Water ◽  
Development And Validation

The present study describes the development and validation of a new stability indicating RP-HPLC method for simultaneous estimation of elbasvir and grazoprevir in bulk and pharmaceutical dosage form. The chromatographic separation was done by using reverse phase YMC column (4.6 x 250mm, 5μm).The mobile phase used was mixture of HPLC grade water acetonitrile (70:30V/V) at flow rate of 1ml/ min in isocratic mode and detection was carried out using PDA detector at 244nm.The developed method showed a good linearity in the range of 100-500μg/mL for elbasvir and 200-1000 μg/mL for grazoprevir with regression co-efficient of 0.999 for both the drugs. The % recovery of drugs was found to be 100.1% for elbasvir and 100.38% for grazoprevir. The proposed stability indicating method was accurate, precise, robust, stable and specific. The developed method was validated in accordance with ICH guidelines.

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