QbD based RP-HPLC Method Development and Validation for Estimation of Evogliptin Tartrate in Pharmaceutical Dosage Form

DOI:

https://doi.org/10.37285/ijpsn.2024.17.6.5

Authors

  • Khushbu Patel Department of Pharmaceutical chemistry and Quality Assurance, Shri Sarvajanik Pharmacy College, Gujarat Technology University, Mehsana
  • C. N. Patel Department of Pharmaceutical chemistry and Quality Assurance, Shri Sarvajanik Pharmacy College, Gujarat Technology University, Mehsana
  • Henee Patel Department of Pharmaceutical chemistry and Quality Assurance, Shri Sarvajanik Pharmacy College, Gujarat Technology University, Mehsana

Abstract

Result: The developed method was optimized with the help of response surface  methodology such as BBD design in design expert software. This proposed method  was validated as per ICH Q2 recommendation. With a correlation coefficient of 0.9935,  the technique demonstrated linearity having 25-150 µg/mL concentration. Less than  2% RSD was reported for precision, while 99.81 - 99.95 % was found for accuracy.  

Conclusion: It is possible to effectively use the proposed developed HPLC method  for routine analysis of Evogliptin tartrate in tablet form since it was straightforward,  accurate, and environmentally friendly. 

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Keywords:

Evogliptin tartrate, Method Validation, RP-HPLC Method, Quality by Design. ANOVA study, DPP-IV inhibitors

Published

2025-01-03

How to Cite

1.
Patel K, Patel CN, Patel H. QbD based RP-HPLC Method Development and Validation for Estimation of Evogliptin Tartrate in Pharmaceutical Dosage Form . Scopus Indexed [Internet]. 2025 Jan. 3 [cited 2025 Jan. 18];17(6). Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/3469

Issue

Section

Research Articles

References

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Astha P. Sanyal, Khushbu K. Patel, Ushma B. Patel and Dr. Chhaganbhai N. Patel. Analytical Method Development and Validation for Estimation of Saroglitazar Magnesium in Pharmaceutical Dosage Form by Quality by Design Approach. World Journal of Pharmaxy and Pharmaceutical Sciences, 2020; 9(4):1267- 1281.

Divyesh Sharma, Khushbu Patel and Dr. C. N. Patel. Qbd: a new era of pharmaceutical drug development. European Journal of Pharmaceutical and Medical Research. 2021; 8(5):688-694.

Priya B. Shah, Pruthviraj K. Chaudhry, Khushbu K. Patel and Dr. C. N. Patel. Qbd – a novel setup for the analytical method development. World Journal of Pharmacy and Pharmaceutical Sciences. 2021;10(5):1645-1662.

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