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The Thai Journal of Pharmaceutical Sciences

Abstract

Background: In the present study, a simple, sensitive, rapid, accurate, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method with diode array detection was developed and validated for simultaneous estimation of Metformin hydrochloride (MET) and Ranolazine (RANO) in a synthetic mixture. Material and Method: The method was developed using isocratic elution mode on a reversed-phase. Chromatographic separation was performed on ACE CN C18 (250 mm, 4.5 mm, 5 μm) column and a mobile phase consisting of methanol: acetonitrile:ammonium formate (45:45:10% v/v/v) with 10% formic acid to adjust the pH to 6.0, at a flow rate of 1.0 ml/min. Detection and quantification of all the analytes were carried out at 230 nm using a photodiode array detector. Result: The method was found to be linear in the range of 1–50 μg/ml for RANO and 2–100 μg/ml for MET. Percentage recovery was found in the range of 99.07–101.53% for RANO and 99.59–100.45% for MET. The RSD of precision and repeatability was found lower than 1% for each drug. Validation of the method was carried out as per International Council on Harmonization guideline Q2 (R1). Conclusion: The proposed RP-HPLC method can be highly suitable for the analysis of RANO and MET without interference.

Publisher

Faculty of Pharmaceutical Sciences, Chulalongkorn University

First Page

287

Last Page

292

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Pharmacology Commons

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