DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND REPAGLINIDE IN TABLET DOSAGE FORM

Abstract

A simple, rapid, and specific reversed-phase high performance liquid chromatographic method for simultaneous estimation of Metformin hydrochloride (MET) and Repaglinide (RPG) in a tablet dosage form has been developed and validated. HPLC analysis was performed on a C ₁₈ column with 90:10 (v/v) acetonitrile-water as mobile phase at a flow rate of 1.0 mL min⁻¹. UV detection was performed at 223 nm. Total run time was 10 min; Metformin hydrochloride and Repaglinide were eluted with retention times of 2.72 min and 6.13 min, respectively. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH guidelines. Validation revealed that the method is specific, rapid, accurate, precise, reliable, and reproducible. The high recovery and low coefficients of variation confirmed the suitability of the method for simultaneous analysis of the two drugs in tablet dosage form.

Keywords:

• analytical method development
• metformin hydrochloride
• repaglinide
• RP HPLC
• tablet dosage form
• validation

ACKNOWLEDGMENT

The authors are thankful to the Head, School of Pharmacy, Devi Ahilya University, Indore and Vice-Chancellor, Devi Ahilya University, Indore for providing facilities to carry out the research work. One of the authors (MJ) is thankful for AICTE for providing a Junior Research Fellowship.

Notes

SD, standard deviation; COV, coefficient of variance.