Development and validation of RP-HPLC method for Empagliflozin and Metformin HCL

Authors

  • Sushil D. Patil Department of Pharmaceutical Chemistry, SNJB’s (Jain Gurukal) Shriman Sureshdada Jain College of Pharmacy, Neminagar, Chandwad-423101, Savitribai Phule Pune University, Pune, India
  • Sunil V. Amurutkar Department of Pharmaceutical Chemistry, SNJB’s (Jain Gurukal) Shriman Sureshdada Jain College of Pharmacy, Neminagar, Chandwad-423101, Savitribai Phule Pune University, Pune, India
  • Chandrashekhar D. Upasani Department of Pharmaceutical Chemistry, SNJB’s (Jain Gurukal) Shriman Sureshdada Jain College of Pharmacy, Neminagar, Chandwad-423101, Savitribai Phule Pune University, Pune, India

Abstract

A simple, specific and accurate RP-HPLC method was developed and validated for simultaneous determination of Empagliflozin and Metformin hydrochloride in bulk and Pharmaceutical dosage form. Chromatographic separation was carried out on Grace C18 column (250×4.6mm, 5µm), Methanol: Water pH 3.0 in the ratio of 80:20 % v/v, Flow rate is 0.8 ml/min and UV detection at 227nm.The Retention times of Empagliflozin and Metformin hydrochloride were found to be 2.630 min and 5.133min, respectively. The validation parameter studied were linearity, accuracy, precision, specificity and robustness i.e. pH of the mobile phase on the retention behavior. The proposed method was validated as per ICH guideline

Keywords:

Empagliflozin, Metformin HCL, RP-HPLC, Effect of pH, Analytical method validation

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Published

05-10-2017
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How to Cite

Sushil D. Patil, Sunil V. Amurutkar, and Chandrashekhar D. Upasani. “Development and Validation of RP-HPLC Method for Empagliflozin and Metformin HCL”. Journal of Innovations in Pharmaceutical and Biological Sciences, vol. 4, no. 4, Oct. 2017, pp. 185-6, https://jipbs.com/index.php/journal/article/view/277.

Issue

Volume 4, Issue 4, 2017 (Oct-Dec)

Section

Research Article

Copyright (c) 2017 Sushil D. Patil, Sunil V. Amurutkar, Chandrashekhar D. Upasani

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