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Stability Indicating RP-HPLC-DAD Method For Simultaneous Estimation of Atorvastatin Calcium and Teneligliptin Hydrobromide Hydrate in Synthetic Mixture

Stability Indicating RP-HPLC-DAD Method For Simultaneous Estimation of Atorvastatin Calcium and... Abstract RP-HPLC stability indicating specific, precise, accurate, cost-effective and isocratic method was developed and validated for quantitative analysis of Atorvastatin calcium and Teneligliptin hydrobromide hydrate in synthetic mixture with presence of its degradants. Separation was achieved by using Gemini, C18, using mobile phase composition [Methanol: 20 mM Ammonium acetate (70:30 v/v)] using a flow rate of 1.0 ml/min, injection volume 10µl with UV detection at 245 nm. Atorvastatin calcium and Teneligliptin hydrobromide hydrate were eluted with retention time 7.47min and 4.74min respectively. This method was validated as per ICH guideline Q2(R1). The calibration plots were over the concentration range of 10-100 μg/ml and 5-50 μg/ml for Atorvastatin calcium and Teneligliptin hydrobromide hydrate with correlation coefficient 1 and 0.9999 respectively. Percentage recovery was obtained between 98.00-100.51 % and 98.90-100.7 % for Atorvastatin calcium and Teneligliptin hydrobromide hydrate respectively. In case of Precision, Repeatability and Robustness RSD should be found less than 2. LOD were found to be 1.22 μg/ml and 0.54 μg/ml and LOQ were found to be 3.70 μg/ml and 1.64 μg/ml for Atorvastatin calcium and Teneligliptin hydrobromide hydrate respectively. The results showed that the developed method is appropriate for the routine analysis of Atorvastatin calcium and Teneligliptin hydrobromide hydrate in a synthetic mixture in presence of its degradants. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Stability Indicating RP-HPLC-DAD Method For Simultaneous Estimation of Atorvastatin Calcium and Teneligliptin Hydrobromide Hydrate in Synthetic Mixture

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Stability Indicating RP-HPLC-DAD Method For Simultaneous Estimation of Atorvastatin Calcium and Teneligliptin Hydrobromide Hydrate in Synthetic Mixture

Abstract

Abstract RP-HPLC stability indicating specific, precise, accurate, cost-effective and isocratic method was developed and validated for quantitative analysis of Atorvastatin calcium and Teneligliptin hydrobromide hydrate in synthetic mixture with presence of its degradants. Separation was achieved by using Gemini, C18, using mobile phase composition [Methanol: 20 mM Ammonium acetate (70:30 v/v)] using a flow rate of 1.0 ml/min, injection volume 10µl with UV detection at 245 nm....
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Publisher
Taylor & Francis
Copyright
© 2022 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2022.2131467
Publisher site
See Article on Publisher Site

Abstract

Abstract RP-HPLC stability indicating specific, precise, accurate, cost-effective and isocratic method was developed and validated for quantitative analysis of Atorvastatin calcium and Teneligliptin hydrobromide hydrate in synthetic mixture with presence of its degradants. Separation was achieved by using Gemini, C18, using mobile phase composition [Methanol: 20 mM Ammonium acetate (70:30 v/v)] using a flow rate of 1.0 ml/min, injection volume 10µl with UV detection at 245 nm. Atorvastatin calcium and Teneligliptin hydrobromide hydrate were eluted with retention time 7.47min and 4.74min respectively. This method was validated as per ICH guideline Q2(R1). The calibration plots were over the concentration range of 10-100 μg/ml and 5-50 μg/ml for Atorvastatin calcium and Teneligliptin hydrobromide hydrate with correlation coefficient 1 and 0.9999 respectively. Percentage recovery was obtained between 98.00-100.51 % and 98.90-100.7 % for Atorvastatin calcium and Teneligliptin hydrobromide hydrate respectively. In case of Precision, Repeatability and Robustness RSD should be found less than 2. LOD were found to be 1.22 μg/ml and 0.54 μg/ml and LOQ were found to be 3.70 μg/ml and 1.64 μg/ml for Atorvastatin calcium and Teneligliptin hydrobromide hydrate respectively. The results showed that the developed method is appropriate for the routine analysis of Atorvastatin calcium and Teneligliptin hydrobromide hydrate in a synthetic mixture in presence of its degradants.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Sep 3, 2022

Keywords: Atorvastatin calcium; Teneligliptin hydrobromide hydrate; Reverse phase-High performance liquid chromatography; Stability indicating method; Synthetic mixture

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