Development and Validation of HPLC Method for Simultaneous Estimation of Metformin HCl with Ertugliflozin L-Pyroglutamic Acid in Tailored Formulation

Muhammad Ashraf; Shaista Zafar; Rustem Zairov; Sana Shaikh; Syed Moazzam Haider; Nida Ali; Kamran Shaikh; Mohsin Ali

doi:10.52568/001612/JCSP

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Development and Validation of HPLC Method for Simultaneous Estimation of Metformin HCl with Ertugliflozin L-Pyroglutamic Acid in Tailored Formulation

Author(s)

Muhammad Ashraf Department of Chemistry, Faculty of Science, University of Karachi, Karachi-75270, Pakistan; Quality Operations, Genix Pharma Pvt. Ltd. Korangi Creek Road, Karachi-75190, Pakistan.

Shaista Zafar Faculty of Pharmacy, Iqra University- North campus, Karachi, Pakistan.

Rustem Zairov Alexander Butlerov Institute of Chemistry, Kazan Federal University, 18 Kremlevskaya Street, 420008 Kazan, Russian Federation; Arbuzov Institute of Organic and Physical Chemistry, FRC Kazan Scientific Center of RAS, Arbuzov str.,8, 420088 Kazan, Russian Federation.

Sana Shaikh Department of Chemistry, Faculty of Science, University of Karachi, Karachi-75270, Pakistan; HEJ Research Institute of Chemistry, International Centre for Chemical and Biological Sciences, University of Karachi, Karachi-75270, Pakistan.

Syed Moazzam Haider HEJ Research Institute of Chemistry, International Centre for Chemical and Biological Sciences, University of Karachi, Karachi-75270, Pakistan.

Nida Ali Department of Chemistry, Faculty of Science, University of Karachi, Karachi-75270, Pakistan.

Kamran Shaikh Quality Operations, Genix Pharma Pvt. Ltd. Korangi Creek Road, Karachi-75190, Pakistan.

Mohsin Ali Department of Chemistry, Faculty of Science, University of Karachi, Karachi-75270, Pakistan; Alexander Butlerov Institute of Chemistry, Kazan Federal University, 18 Kremlevskaya Street, 420008 Kazan, Russian Federation.

Abstract

Summary: The present study introduced an innovative and quick RP-HPLC approach for simultaneous determination of Metformin HCl (MET) and Ertugliflozin L-pyroglutamamic acid (ERT). This new method is simple, accurate, precise and highly sensitive. The separation of both drugs was optimized at 40°C using HPLC column (C8, 4.6 x 150mm 5 microns) and mobile phase comprising of triethylamine in sodium octane sulfonate (pH 4) : MeOH: ACN in a ratio of 45:45:10 respectively, with a flow rate of 1.0 ml /min. The specificity of method showed that there was no interference from placebo or diluent during the drug's retention period. Accuracy and linearity studies conducted at different concentrations displayed good precision and the calibration curves exhibited high correlation i.e. R2= 0.9982 and 0.9996 for ERT and MET, respectively. Precision was assessed for repeatability and intermediate precision, both delivering satisfactory results. Robustness was evaluated under different conditions, including wavelength and flow rate variations, showing acceptable results. Limits of detection (LOD) and quantification (LOQ) demonstrated good sensitivity. The accuracy and reliability of the suggested approach for the simultaneous measurement of MET and ERT are guaranteed by the analytical method validation. Comparative analysis of the bespoke new formulation's complete dissolution profile (CDP), Ertozin-M (7.5/500mg) with innovator tablet and Segluromet (7.5/500mg) was also observed at three different pH mediums (0.1 N HCl and buffer solutions of pH 4.5 and pH 6.8). This study was conducted according to International Council for Harmonization (ICH) guideline Q2(R2) on validation of analytical procedures and Q4B annex 7(R2) for Dissolution Test. The developed HPLC method was found highly suitable for combined estimation of Metformin HCl and Ertugliflozin L-pyroglutamic acid in quality control routine analysis for development of customized pharmaceutical formulations.

Publication Details

Page(s) 590-599

DOI 10.52568/001612/JCSP

Published Journal: Journal of Chemical Society of Pakistan, Volume: 46, Issue: 6, Year: 2024

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Keywords

RP-HPLC, metformin HCl, Analytical method validation, Ertugliflozin Lpyroglutamic acid, Dissolution profile

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