Development and Validation of a HPLC method for the Determination of Metformin hydrochloride, Nateglinide and Pioglitazone hydrochloride in Multicomponent Formulation
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A simple, rapid, and precise reverse-phase high-performance liquid chromategraphic method for simultaneous analysis of Metformin hydrochloride, Nateglinide, and Pioglitazone hydrochloride in a tablet dosage form has been developed and validated. Chromatography was performed on a 25cm × 4.6mm i.d., 5-μm particle, Cis column with 85:15 (v/v) methanol: 20mM potassium dihydrogen phosphate buffer as mobile phase at a flow rate of 1.2ml/min. UV detection at 227nm; Metformin hydrochloride, Nateglinide, and Pioglitazone hydrochloride were eluted with retention times of 2.15, 3.787, and 4.57 min, respectively. The method was validated 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 50-250mg/ml for Metformin hydrochloride, 3.0-15.0mg/ml for Nateglinide, and 2-10mg/ml for Pioglitazone hydrochloride. Limits of detection were 0.03, 0.22, and 0.008mg/ml and limits of quantification were 0.09, 0.67, and 0.02mg/ml for Metformin hydrochloride, Nateglinide, and Pioglitazone hydrochloride, respectively. The high recovery and low coefficients of variation confirm the suitability of the method for simultaneous analysis of the three drugs in tablets. Statistical analysis proves that the method is suitable for the analysis of Metformin hydrochloride, Nateglinide, and Pioglitazone hydrochloride as a bulk drug and in pharmaceutical formulation with out any interference from the excipients. It may be extended to study the degradation kinetics of three drugs and also for its estimation in plasma and other biological fluids.
Determination, Metformin hydrochloride, Nateglinide, Pioglitazone hydrochloride, Multicomponent.