Stability-Indicating RP-HPLC Assay Method for Estimation of Ketoprofen in Bulk and Tablets

Abstract

Objective To develop and validate a simple, precise, accurate and stability-indicating reverse phase-high performance liquid chromatographic (RP-HPLC) assay method for the estimation of Ketoprofen in bulk and pharmaceutical tablet dosage forms. Methods Chromatographic separation was achieved using an Enable C18 column (250 mm × 4.6 mm, 5 μm) and a mobile phase comprising aqueous phosphate buffer (pH 3.0): acetonitrile (40:60 v/v) at a flow rate of 1.0 ml/min. UV detection was performed at 260 nm. The method was validated according to ICH Q2(R1) guidelines for linearity, precision, accuracy, robustness, LOD and LOQ. Forced degradation studies were performed under acidic, basic, oxidative, thermal and photolytic conditions as per ICH Q1A(R2). Results The retention time of Ketoprofen was found to be 4.53 min. The method was linear in the range of 10–100 μg/ml with a correlation coefficient (r²) of 0.9999. The mean % recovery was 99.13 and %RSD for repeatability was below 0.5%. LOD and LOQ were found to be 0.35 μg/ml and 1.06 μg/ml, respectively. The drug was found stable under acidic, hydrolytic and thermal conditions but degraded in basic, photolytic and oxidative environments, indicating the stability-indicating capability of the method. Conclusion The developed RP-HPLC method is simple, rapid, specific, sensitive and validated as per ICH guidelines. It can be effectively employed for routine quality control and stability testing of Ketoprofen in bulk and tablet dosage forms.