DEVELOPMENT AND VALIDATION OF LC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ROSIGLITAZONE MALEATE AND GLIMEPIRIDE IN PHARMACEUTICAL DOSAGE FORM
SHWETA SHASHIKAT HAVELE AND SUNIL RAJARAM DHANESHWAR
Malaysian Journal of Pharmaceutical Sciences
A simple, precise and accurate high performance liquid chromatography (HPLC) method was developed for simultaneous quantitative determination of rosiglitazone maleate and glimepiride in pure forms and in pharmaceutical formulation. The separation was achieved by C18 column using methanol:20 mM ammonium dihydrogen phosphate [78:22 (v/v); pH 3.85] as mobile phase at a flow rate of 1 mL/min and detection at 240 nm. Separation was complete in less than 10 min. Linearity, accuracy and precision were found to be acceptable over the ranges 0.8–4.0 µg/mL for rosiglitazone maleate and 0.4–2.0 µg/mL for glimepiride. This method was found to be specific, reproducible, precise and accurate. Due to its simplicity and accuracy the method is particularly suitable for routine pharmaceutical quality control.
HPLC, Rosiglitazone maleate, Glimepiride, Multicomponent formulation