Validated stability-indicating RP-HPLC UV method for simultaneous determination of metformin and repaglinide

Abstract

Summary.A simple, rapid, precise, and accurate, stability-indicating reversed phase high performance liquid chromatographic method was developed and validated for simultaneous determination of metformin HCl and repaglinide. The chromatographic separation was achieved on YMC Pack AM ODS (5 μm, 250 mm length × 4.6 mm i.d.) column at a detector wavelength of 210 nm, using an isocratic mobile phase consisting of methanol and 10 mM potassium dihydrogen phosphate buffer (pH 2.5) in a ratio of 70:30 v/v at a flow rate of 1 mL min −1 . The retention times for metformin and repaglinide were found to be 2.6 and 11.3 min, respectively. The drugs were exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. Validation of the method was carried out as per International Conference on Harmonization (ICH) guidelines. Linearity was established for metformin and repaglinide in the range of 5-200 μg mL −1 and 1-200 μg mL −1 , respectively. The limits of detection were 0.3 μg mL −1 and 0.13 μg mL −1 for metformin and repaglinide, respectively. The method was found to be specific and stability-indicating as no interfering peaks of degradants and excipients were observed. The proposed method is hence suitable for application in quality-control laboratories for quantitative analysis of both the drugs individually and in combination, since it is simple and rapid with good accuracy and precision.

Multifunctional polymersomes for cytosolic delivery of gemcitabine and doxorubicin to cancer cells

“…Although liquid chromatographic methods are frequently-used for simultaneous determination of two or more drugs, they are expensive and time consuming [66, 67]. Specifically, we selected two wavelengths so that doxorubicin has equal absorbance at both the wavelengths and that, at one of the wavelengths, gemcitabine absorbance is negligible.…”

Analytical Method Development and Validation of Metformin, Voglibose, Glimepiride in Bulk and Combined Tablet Dosage Form by Gradient RP-HPLC

“…Detailed survey of the literature revealed, several methods are reported such as Spectrophotometry, 6 reversed-phasehigh performance liquid chromatography (RP-HPLC), [7][8][9][10][11][12][13] high performance thin layer chromatography, 14 gas chromatography, 15 LC in biological fluids 16 for MET alone as well as in combination with other drugs using pharmaceutical formulations. So far, methods are reported for the estimation of GLI alone such as UV spectrophotometric method, 23 in biological fl uids 24 using pharmaceutical formulation and methods in combination based on RP-LC, 25 HPLC, 26 High performance thin layer chromatography 27 using pharmaceutical formulation.…”

Analytical quality by design in the development of a cyclodextrin‐modified capillary electrophoresis method for the assay of metformin and its related substances

“…Analysis of MET, I A and I D has been carried out by HILIC , and other HPLC methods have been developed for the analysis of MET and I A and MET, I A , I B , I C , I D . Different stability indicating methods have been presented, including HPTLC , HPLC , and Ultra Performance LC . CZE has been used for the analysis of MET in pharmaceutical preparations, alone or in combination with other drugs .…”