RP-UPLC method development and validation for simultaneous estimation of vildagliptin with metformin hydrochloride and ciprofloxacin hydrochloride with dexamethasone sodium phosphate

Abstract

A novel, sensitive and rapid assay method using Ultra Performance Liquid Chromatography (UPLC) has been developed and validated as per ICH guideline for simultaneous determination of two binary mixtures; vildagliptin with metformin hydrochloride and ciprofloxacin hydrochloride with dexamethasone sodium phosphate. Chromatographic separation was achieved on a Phenomenex C₁₈ column (100 mm, 2.1 mm i.d.,    1.8 μm) using an isocratic method with mobile phase of potassium di-hydrogen phosphate (pH 4): acetonitrile in the ratio 70:30 (v/v) for vildagliptin/metformin mixture or 80:20 (v/v) for ciprofloxacin/dexamethasone mixture. The flow rate was 1 mL/min, temperature of the column was maintained at ambient and detection was made at 220 or 254 nm for the two mixtures, simultaneously.  Linearity studies indicated that the drugs obeys Beer’s law over the range of 0.5-5 μg/mL for vildagliptin, 5-50 μg/mL for metformin hydrochloride while ranges from      2-20 μg/mL for both ciprofloxacin hydrochloride and dexamethasone sodium phosphate. The proposed method is precise, accurate, linear, robust and fast. The short retention time allows the analysis of a large number of samples in a short period of time and, therefore, should be cost-effective for routine analysis in the pharmaceutical industry.