Abstract

SIMULTANEOUS METHOD DEVELOPMENT AND VALIDATION OF METFORMIN AND PIOGLITAZONE HYDROCHLORIDE

*P. Sirisha, J. V. C. Sharma, MD. Waheeda Fatima, L. Sowmya, K. Mohan Krishna, N. Alekhya

ABSTRACT

A rapid, sensitive, precise and accurate HPLC method coupled with a photodiode array detector was developed, optimized and validated for the estimation of Metformin and Pioglitazone in bulk and tablet dosage forms. The chromatographic separation was achieved using a KH2PO4:Methano(60:40) SUPLECO,C8,250X4. column (6mm × 4.6)mm i.d., 5 μm particle size) at 25°C temperature. The Methanol mobile phase consisted of 0.1M dipotassium hydrogen phosphate and methanol (60:40, v/v). The mobile phase was delivered at 1.0ml/min and the analyte was monitored at 245 nm. The method was successfully validated in accordance to International Conference on Harmonization. The retention time of Metformin and Pioglitazone was found to be 6 min, and the calibration curve was linear in the concentration range of 50-150μg/ml (R2 = 0.9992). The limit of detection and the limit of quantitation were found to be 0.109μg/ml and 0.364 μg/ml, respectively. The proposed method is accurate (percent recoveries were in the range of 99.56-100.09%) and precise (percent relative standard deviation - 0.047 %). No chromatographic interferences from the tablet excipients and components of mobile phase were found. The proposed method was found to be suitable for the quantitative determination of Metformin and Pioglitazone in tablet dosage forms.

Keywords: Metformin and Pioglitazone, HPLC, validation, analysis.