ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ALISKIREN AND VALSARTAN IN BULK AND TABLET DOSAGE FORM BY RP-HPLC

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (07) ◽  
pp. 5-9
Author(s):  
L Kalyani ◽  
◽  
A. L. Rao
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Relative Standard ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise and accurate RP-HPLC method was developed and validated for the simultaneous estimation of aliskiren and valsartan in combined tablet dosage form. The chromatographic separation of the two drugs was achieved on Symmetry C8 column (250 x 4.6 mm, 5 μm). The mobile phase consisted of acetate buffer: acetonitrile (60:40 V/V) and pH was adjusted to 5.8 with glacial acetic acid was delivered at the flow rate of 1.4 mL/min and detection was performed at 220 nm. Separation was completed within 4 minutes. The calibration curves were linear with a correlation coefficient of 0.999 over the concentration range of 7.5 to 75 µg/mL of aliskiren and 8 to 80 µg/mL of valsartan. The relative standard deviation (RSD) was found

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LINAGLIPTIN AND EMPAGLIFLOZIN

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (05) ◽  
pp. 68-71
Author(s):  
A Lakshmana Rao ◽  
◽  
T. Prasanthi ◽  
E. L Anusha
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

A simple, accurate and precise RP-HPLC method was developed for the simultaneous estimation of the linagliptin and empagliflozin in tablet dosage form. Chromatogram was run through Kromasil 250 x 4.6 mM, 5mM column, mobile phase containing 0.1% o-phosphoric acid buffer and acetonitrile in the ratio of 60:40%v/v was pumped through column at a flow rate of 1 mL/min. The optimized wavelength was 230 nm. Retention times of linagliptin and empagliflozin were found to be 2.759 min and 2.139 min. %RSD of the Linagliptin and Empagliflozin were found to be 0.5 and 0.6 respectively. Percentage assay was obtained as 99.91% and 100.15% for linagliptin and empagliflozin, respectively. LOD, LOQ values obtained for linagliptin and empagliflozin were 0.23 μg/ml and 0.44 μg/mL and 0.70 μg/mL and 1.34 μg/mL, respectively. Thus, the current study showed that the developed RP-HPLC method is sensitive and selective for the estimation of linagliptin and empagliflozin in combined dosage form.

RP-HPLC Method Development and Validation for the simultaneous estimation of Atazanavir sulphate and Ritonavir in bulk and tablet dosage form

2014 ◽  
Vol 1 (3) ◽  
pp. 50
Author(s):  
Ananda Thangadurai Subramaniam ◽  
Jambulingam Munusamy ◽  
Saravanakumar Sengodan ◽  
Kamalakannan Danapal ◽  
Haritha D Siva Ganga Lakshmi ◽  
...  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CURCUMIN AND CYCLOSPORINE BY RP-HPLC

2018 ◽  
pp. 26-33
Author(s):  
Neha Desai ◽  
Munira Momin ◽  
Upasana Singh ◽  
Tabassum Khan ◽  
Atul Sherje
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Relative Standard ◽  
Method Development And Validation ◽  
Precision Study ◽  
Development And Validation

Objective: The present work was undertaken with an aim to develop and validate a rapid reverse-phase high-performance liquid chromatography (RP-HPLC) method for the estimation of curcumin and cyclosporine in the capsule dosage form. Methods: The RP-HPLC method for the simultaneous estimation of curcumin and cyclosporine was developed using Agilent (Infinity 1260) HPLC system and Eclipse XDB-C18 (4.6 x 150 mm i.d., 5µ) stationary phase. The optimized mobile phase comprised of acetonitrile: water: methanol (50: 10: 40 v/v/v) pumped at a flow rate of 0.5 ml/min. Separation of drugs was achieved in an isocratic mode and elution was monitored using PDA detector at 214 nm. The method was validated as per ICH-Q2R1 guidelines. Results: Retention time of the curcumin and cyclosporine were found to be 3.073 min and 6.373 min with the correlation coefficient (R2) of 0.9993 and 0.998 respectively. The response of curcumin and cyclosporine was found linear in the concentration range of 8-48 μg/ml and 4-24 μg/ml respectively. The percent recovery values were found in the range of 97-103% indicating satisfactory accuracy of the method. The percent relative standard deviation (% RSD) values for the precision study was less than 2 which suggest that the method is precise. Conclusion: The proposed method was found accurate, precise and specific for the determination of curcumin and cyclosporine in bulk as well as in capsule dosage form. Thus, the present method can be used for routine analysis and quality control of curcumin and cyclosporine in bulk and capsule dosage form.

scholarly journals Novel Stress Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and its Formulation

2018 ◽  
Vol 34 (5) ◽  
pp. 2554-2561
Author(s):  
D. China Babu ◽  
C. Madhusudhana Chetty ◽  
S. K. Mastanamma
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Potassium Dihydrogen ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation

A selective, sensitive RP-HPLC method was developed for the simultaneous estimation of the Ertugliflozin (ETR) and Sitagliptin (SGT) in bulk and its dosage form. The separation and determination was carried on water’s C18 column capacitate (250X4.6 mm, 5 µm particle size), retention times of Ertugliflozin and Sitagliptin were found to be 2.39 and 4.60 min respectively. The wavelength was fixed at 215nm with PDA detection. The mobile phase was consisted mixture of 0.5 mM potassium dihydrogen ortho phosphate buffer: Methanol in the ratio of 55:45 v/v, pH 5.3 was adjusted with HCl and flow of mobile phase was maintained 1mL/min. The calibration curve was linear and regression co-efficient (R2) value found to be 0.999 and concentration ranging from 37.5-112.5 and 250-750 µg/mL for Ertugliflozin & Sitagliptin respectively. The quantization limit and detection limit of the method were found 0.1 & 0.3 µg/ml and 0.4&1µg/ml for Ertugliflozin & Sitagliptin.

scholarly journals RP-HPLC Method Development and Validation for Simultaneous Estimation of Thymoquinone and Curcumin in Dosage form

2021 ◽  
pp. 53-62
Author(s):  
Prajakta Jagtap ◽  
Namrata Mahajan ◽  
Anjali Parte ◽  
Jeeja Pananchery ◽  
Ashish Jain
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Allowable Limit ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Relative Standard ◽  
Method Development And Validation ◽  
Development And Validation

Aim: The aim of work is to develop and validate simple, specific, accurate, precise HPLC method for the estimation of Curcumin (CUR) and Thymoquinone (THQ) simultaneously in bulk and its formulation as per ICH guidelines for analytical method development and validation. Study Design: Developing RP-HPLC method using C-18 Inertsil column and optimization of variables for estimation of Thymoquinone and Curcumin in bulk and formulation. Place and Duration of Study: The present work was carried out at Shri D. D. Vispute College of Pharmacy and Research Center, Panvel in year 2021. Methodology: The RP-HPLC method was developed with an isocratic condition of mobile phase comprising acetonitrile and water in a ratio of (82:18) v/v, at a flow rate of 0.9 mL/minute over Inertsil ODS, 250× 4.6 mm, 5 µm column, at 30°C column oven temperature. Photodiode array at 256 nm was used for detection Results: Retention time for curcumin and thymoquinone was found to be 3.5 and 4.3 mins respectively. The method showed excellent linear response in concentration range of 4-18 µg/mland 10-45 µg/mlfor thymoquinone and curcuminrespectively with correlation coefficient (R2) values of0.999 for both. System precision and method precision studies were less than the maximum allowable limit percentage of relative standard deviation ≤ 2.0 i.e., 1.61 % and 1.62 % for curcumin and 0.47 % and 0.42 % for thymoquinone respectively. Mean % Recovery for both the drugs were within acceptance limits. The developed and validated HPLC method is simple, accurate, precise and suitable for analysis as all the results were within acceptance criteria. Conclusion: The developed RP-HPLC method at single wavelength was validated according to ICH guideline with respect to system suitability, specificity, linearity, accuracy, precision and robustness and can be used for routine quality monitoring of drug in pharmaceutical dosage form.

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