DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF KETOROLAC TROMETHAMINE IN DRUG SUBSTANCE AND ITS PHARMACEUTICAL FORMULATIONS

A rapid and sensitive reverse phase High Performance Liquid Chromatographic [RP-HPLC] method was developed for the estimation of Ketorolac tromethamine [KTT] in pure and its capsule dosage forms. The method was validated as per International Conference on Harmonization [ICH] guidelines. The mobile phase used in this study is a mixture of tetrahydrofuran and monobasic ammonium phosphate buffer (pH-3.0) in the ratio of 30: 70% v/v. Stationary phase was waters spherisorb C-8 reverse phase column (250x4.6mm, 5 mu m) dimensions at 40 degrees c temperature. The analysis was performed with run time of 10.0 minutes at a flow rate of 1.50ml/min. The KTT was monitored at 313nm with UV detection and KTT was eluted at 7.20min. The method was linear (r2 = 0.999) at concentration ranging from 100 to 600 mu g/ml, precise (intra-day relative standard deviation [RSD] and inter-day RSD values < 1.0%), accurate (mean recovery = 99.5%), specific and robust. Detection and quantification limits were 27.0 mu g/ml and 92.0 mu g/ml, estimated from linearity by regression method. The results showed that the proposed method is suitable for the precise, accurate and rapid determination of KTT in bulk, its capsule dosage forms.