Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

Tulsi M. Tilva* and Pinkal H. Patel

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Abstract

A RP-HPLC method were developed and validated for simultaneous estimation of Phenylephrine Hydrochloride (PE) and Ketorolac Tromethamine (KETO). The separation was achieved on an Enable C18 (250mm × 4.6mm i.d., 5μm particle size) with an isocratic system of Methanol: Phosphate buffer 0.1% TEA (pH 3.3 by OPA) in the ratio of 55:45v/v. The retention time for PHE and KETO was obtained as 3.690 min and 5.890 min respectively with a flow rate of 1.0ml/min at detection wavelength 284 nm. The linearity of the proposed method was investigated in the range of 10-50 μg/ml and 3-15 μg/ml for PHE and KETO respectively. The developed method was validated as per ICH guideline and found to be satisfactory.

Keywords: Ketorolac Tromethamine (KETO), Phenylephrine Hydrochloride (PHE), RP-HPLC, Validation.