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

Rahul Singh, Ashish Pathak, Pooja Chawla


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 (60:40, 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.


HPLC, Reverse phase, Ketorolac, Sparfloxacin

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