A simple, rapid, and precise reversed-phase high-performance liquid chromatographic method for simultaneous analysis of metformin hydrochloride, pioglitazone hydrochloride, and glibenclamide in a tablet dosage form has been developed and validated. Chromatography was performed on a 25 cm × 4.6 mm i.d., 5-μm particle, C18 column with 55:45 (v/v) acetonitrile — potassium dihydrogen phosphate buffer (pH adjusted to 3.0 ± 0.1 with 5% orthophosphoric acid) as mobile phase at a flow rate of 1.5 mL min−1. UV detection was performed at 230 nm. Total run time was 10 min; metformin hydrochloride, pioglitazone hydrochloride, and glibenclamide were eluted with retention times of 1.362, 3.418, and 7.395 min, respectively. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots were linear over the concentration ranges 200–1000 μg mL−1 for metformin hydrochloride, 200–1000 μg mL−1 for pioglitazone hydrochloride, and 50–300 μg mL−1 for glibenclamide. Limits of detection were 6.3, 15.4, and 8.2 ng mL−1 and limits of quantification were 19.09, 46.66, and 24.84 ng mL−1 for metformin hydrochloride, pioglitazone hydrochloride, and glibenclamide, respectively. The high recovery and low coefficients of variation confirm the suitability of the method for simultaneous analysis of the three drugs in tablets. The validated method was successfully used for quantitative analysis of triglycomate tablets.
. British Pharmacopoeia, Vol. I, HMSO, London, 2002, p. 1123.
British Pharmacopoeia, Vol. I, HMSO, London, 2002, p. 1123.)| false