Rapid and sensitive RP-HPLC analytical method development and validation of Pioglitazone hydrochloride

摘要

A simple, specific, accurate and isocratic reversed phase - HPLC method was developed and subsequently validated for the determination of Pioglitazone Hydrochloride. Separation was achieved with an Symmetry - Extend - C18 HPLC column 150mm in length and having an internal diameter of 4.6mm. A mobile phase comprising 0.01M Buffer: Methanol in the volume ratio of (40:60) was developed. The detection was carried out using a UV-detector set at a wavelength of 240nm. Validation experiments were performed to demonstrate System suitability, precision, linearity and Range, Accuracy study, stability of analytical solution and robustness. The method was linear over the concentration range of 1-200μg/ml and get the correlation Regration (r2) 0.999, showed good recoveries (99.3 - 103.2). The method can be used for quality control assay of Pioglitazone Hydrochloride.