SIMULTANEOUS ESTIMATION OF PHENYLEPHRINE HYDROCHLORIDE AND KETOROLAC TROMETHAMINE USING UV SPECTROPHOTOMETRIC AND HPLC METHODS

This study involve development of a simple, sensitive, precise, accurate and economic HPLC method and two UV methods for simultaneous estimation of phenylephrine HCl (Phe) and ketorolac tromethamine (Ket). The UV methods are based upon absorption correction and multicomponent analysis approach. Wavelength maxima (λmax) selected for Phe and Ket were 273 nm and 323 nm respectively. Selected linearity ranges for Phe and Ket were 12-42 ppm and 4-14 ppm respectively for UV methods. HPLC method was developed using Waters HILIC (Hydrophilic interaction liquid chromatography) column having dimension of 150 mm x 4.6 mm, 5 μm. Mobile phase used was acetate buffer (pH 3.2; 10mM): MeOH: ACN:: 32:23:45 with flow rate of 1mL/min at detection wavelength of 275nm. Retention time for Phe and Ket were 2.96 and 1.96 min. Linearity ranges for Phe and Ket chosen were 30-60 and 10-20 μg/mL respectively for HPLC method. Thus, selective and robust spectrophotometric and chromatographic methods were developed successfully and also validated for various parameters like accuracy, precision (intra-day and inter-day), linearity and range, limit of detection and limit of quantitation (LOD and LOQ) as per ICH guidelines. %Assay was also determined and found to be in accordance with the label claim. Both the developed methods are quite sensitive for simultaneous identification and analysis of Phe and Ket in bulk.