HPLC determination of ketorolac tromethamine in tablet dosage forms

A simple, specific, precise and accurate reversed phase liquid chromatographic (RP-LC) method has been developed for the determination of ketorolac tromethamine (KTR) in tablet dosage forms. Acetylsalicylic acid was used as internal standard. The chromatographic separation was achieved on a LiChrosorb C₁₈, 250 mm x 4.6 mm, 5 μm column at a detector wavelength of 230 nm and a flow rate of 1.0 ml/min. The mobile phase was composed of 0.1M sodium acetate buffer pH 5.0, acetonitrile and tetrahydrofuran (23:75:2 v/v/v). The retention time of KTR was 3.05 min. The method was validated for the parameters like specificity, linearity, precision, accuracy, limit of quantitation and limit of detection. The method was found to be specific as no other peaks of impurities and excipients were observed. The square of correlation coefficient (R²) was 0.9999 while relative standard deviations were found to be <2.0%. This method can be used for the routine quality control and assay of KTR in pharmaceutical preparations.

Author(s): Boyka G. Tsvetkova, Ivanka P. Pencheva, Plamen T. Peikov

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