Validated reversed phase HPLC method for determination of pioglitazone hydrochloride in bulk drug and tablet formulations

摘要

An accurate, sensitive and precise HPLC method was developed and validated for the routine analysis of pioglitazone hydrochloride in dosage forms. The analyte was chromatographed on a C-18 column using a mixture of acetonitrile and ammonium acetate buffer (pH 5.0) as mobile phase in ratio 60: 40 (v/v) at flow rate 1.0 mL/min. Linearity range was found to be 10-100 mu g/mL with a correlation coefficient r (2) = 0.9984. The method was validated for precision, accuracy, robustness, specificity and sensitivity, using bulk drug samples. Application of method in assay of bulk drug and tablets revealed mean recoveries range from 99.88-100.32%. Due to its simplicity, rapidity, high precision and accuracy, the proposed method may be used for determining pioglitazone hydrochloride in bulk and dosage forms.