Journal of Engineering in Industrial Research

h-index: 18     i10-index: 25

Specific Stability Indicating RP-UPLC Method for Simultaneous Estimation of Atorvastatin Calcium and Teneligliptin Hydrobromide Hydrate

Document Type : Original Research Article

Authors

Amit Kumar J. Vyas 1
Chetan Khandala Khandala 1
Chirag Jadav Jadav 1
Ajay I. Patel 1
Ashvin V. Dudhrejiya Dudhrejiya 1
Sunny R. Shah 2

1 B. K. Mody Government Pharmacy College, Rajkot, Gujarat, India

2 Government Pharmacy College, Gandhinagar, Gujarat, India ‎

https://doi.org/10.48309/jeires.2024.212596
Abstract
A stability-indicating RP-UPLC method was developed for the quantitative analysis of atorvastatin calcium (ATV) and teneligliptin hydrobromide hydrate (TEN) in the presence of degradants. The separation was achieved using an Acquity UPLC BEH C18 column with a mobile phase composed of Methanol, Ammonium Acetate Buffer, and Acetonitrile (60:35:5, pH 6.5, adjusted with OPA). The method was optimized with a flow rate of 1.0 mL/min, an injection volume of 2 µL, and UV detection at 245 nm. The retention times (RT) were 2.2 min for ATV and 0.9 min for TEN. The calibration ranges were 10–30 μg/mL for ATV and 5-15 μg/mL for TEN, with correlation coefficients of 0.9999 and 0.9998, respectively. The method demonstrated accuracy ranging from 99.70-100.07% for ATV and 99.60-100.40% for TEN. The limits of detection (LOD) were 1.8543 μg/mL for ATV and 0.6228 μg/mL for TEN, while the limits of quantification (LOQ) were 1.0319 μg/mL for ATV and 3.1271 μg/mL for TEN. The results confirm that the developed method is robust and suitable for the analysis of a synthetic mixture in the presence of generated degradants.

Keywords

Atorvastatin calcium
Teneligliptin hydrobromide hydrate
Stability-indicating RP-UPLC
Quantitative analysis
Synthetic mixture analysis
ICH guideline (Q2R2)

Subjects

OPEN ACCESS

©2024 The author(s). This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit: http://creativecommons.org/licenses/by/4.0/

 

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Journal of Engineering in Industrial Research
Volume 5, Issue 3
Summer 2024
Pages 142-151

  • Receive Date 03 September 2024
  • Revise Date 25 November 2024
  • Accept Date 24 December 2024

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