Research Journal of Pharmacy and Technology

SCOPUS
  • Year: 2024
  • Volume: 17
  • Issue: 9

RP-HPLC method development and validation for simultaneous estimation of rosuvastatin calcium and teneligliptin hydrobromide hydrate in synthetic mixture

  • Author:
  • Amitkumar J. Vyas1, Harshal M. Vadile1,*, Jayshree P. Godhaniya1, Chirag D. Jadav1, Ajay I. Patel1, Ashok B. Patel2, Ashvin V. Dudhrejiya1, Sunny R. Shah1, Urvi J. Chotaliya1, Devang B. Sheth3
  • Total Page Count: 4
  • Page Number: 4325 to 4328

1B. K. Mody Government Pharmacy College, Rajkot, Gujarat, India, Postal Code: 360003

2Government Pharmacy College, Gandhinagar, Gujarat, India

3LM College of Pharmacy, Ahmedabad, Gujarat, India

Abstract

This study outlines a method using RP-HPLC to analyze Rosuvastatin calcium and Teneligliptin hydrobromide hydrate. The separation was accomplished at λ(245nm) with a 1mL/min F.R with [KH2PO4 buffer (pH 3): Methanol: Acetonitrile (75:20:5 %v/v)] using a C18 (25 cm × 4.6 mm, 5μm). Both were eluted with retention times of 3.19 min and 2.08 min respectively. Linearity was observed across a defined concentration range for both drugs, with high correlation coefficients. Accuracy of the method was confirmed through analysis of known concentrations, indicating its suitability for routine analysis of these compounds in a synthetic mixture.

Keywords

Synthetic mixture, RP-HPLC, ICH guideline, KH2PO4