Method Development and Validation for Simultaneous Estimation of Ketorolac and Sparfloxacin by RP-HPLC.

ABSTRACT

A modified simple, selective, rapid, precise reversed phase high performance liquid chromatography method has been developed and validated for the simultaneous estimation of ketorolac and sparfloxacin. The separation was made in a Hypersil-Keystone C-18 column using a methanol water (6040, v/v) (pH 3.1) as mobile phase at 308 nm. The mobile-phase flow rate and the sample volume injected were 0.9 ml/min and 20 μl, respectively. Retention time of sparfloxacin and ketorolac was found to be 3.181 and 4.473 minutes respectively. The correlation coefficient of both drugs was found to be 0.999. The accuracy of ketorolac was found to be 99.82% - 100.55% whereas for sparfloxacin, it was 99.76% - 99.89%. Over all % RSD was found to be less than 2%. The method was validated according to ICH guidelines with respect to linearity, accuracy, precision, robustness, specificity, etc. The developed method can be used for routine analysis of ketorolac and sparfloxacin in their pharmaceutical dosage forms.