RATIO SPECTRA DERIVATIVE UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE IN IMMEDIATE RELEASE TABLET Original Article RIDDHI PARMAR a* , FALGUNI TANDEL a , NIKITA PATEL a a Received: 08 Feb 2015 Revised and Accepted: 10 Sep 2015 Department of Quality Assurance, Parul Institute of Pharmacy, Limda, Waghodia, Vadodara Email: riddhi.parmar91@yahoo.com ABSTRACT Objective: To develop and validate robust, accurate and precise UV spectrophotometric method for determination of Ketorolac Tromethamine and Phenylephrine Hydrochloride. Methods: Ratio spectra derivative method was developed using water as solvent. The developed method was validated as per International Conference on Harmonization (ICH) guidelines. Results: Linearity of the developed method was 0.9958 and 0.9987 in the range of 4-20 ppm and 12-60 ppm for Ketorolac Tromethamine and Phenylephrine Hydrochloride respectively. % Relative standard deviation (RSD) was found to be less than 2 for Intraday precision and Intermediate precision. % recovery was found to be 98.5–100.27 % and 98.38–101.99 % for Ketorolac Tromethamine and Phenylephrine Hydrochloride respectively. Conclusion: A robust, accurate and precise UV spectrophotometric method was developed and validated as per ICH guidelines. Keywords: Ketorolac Tromethamine, Phenylephrine Hydrochloride, UV spectroscopy, Ratio spectra derivative method. INTRODUCTION Ketorolac Tromethamine, chemically known as 5-benzoyl-2,3- dihydro-1H-pyrrolizine-1-carboxylic acid with 2-amino-2- (hydroxymethyl) propane-1,3-diol (fig. 1), is a Non-steroidal anti- inflammatory drug. Ketorolac Tromethamine is used as an analgesic and antipyretic agent. It is freely soluble in water and methanol. Ketorolac Tromethamine is official in IP, BP and USP and estimated by Potentiometric Titration as per IP [1] and BP [2] and HPLC as per USP [3]. Literature survey showed several reported spectro- photometric [4, 5] and HPLC [6, 7] methods for determination of Ketorolac Tromethamine in pharmaceutical dosage form either as the single component or in combination with other drugs. Phenylephrine Hydrochloride, chemically known as R)-1-(3- Hydroxy phenyl)-2-methyl amino ethanol hydrochloride (fig. 2), is a sympathomimetic drug. Phenylephrine Hydrochloride is used as an anti-allergic agent. It is freely soluble in water and methanol [8].Phenylephrine Hydrochloride is official in IP, BP and USP and estimated by potentiometric titration as per IP [9] and BP [10] and Titration as per USP [11]. Fig. 1: Structure of ketorolac tromethamine Fig. 2: Structure of phenylephrine hydrochloride Literature survey showed several reported spectrophotometric [12, 13] and HPLC [14, 15] methods for determination of Phenylephrine Hydrochloride in pharmaceutical dosage form either as the single component or in combination with other drugs [16, 17]. There are no UV methods available for simultaneous estimation of Ketorolac Tromethamine and Phenylephrine Hydrochloride in combination. So the rational this works to develop robust, accurate and precise UV method for simultaneous estimation of Ketorolac Tromethamine and Phenylephrine Hydrochloride in immediate release tablet. MATERIALS AND METHODS Materials Instrument UV visible spectrophotometer (Shimadzu, model 1800) with UV probe software was used for recording the spectra and measuring the absorbance. Chemicals and reagents Ketorolac Tromethamine was supplied by the Cadila healthcare, Ahmedabad as the gift sample. Phenylephrine Hydrochloride was supplied by the Tuton Pharmaceuticals, Mumbai as the gift sample. For the preparation of solution double distill water was used. Methods Selection of solvent Double distil water was used as a solvent for the preparation of the sample solution. Selection of method Standard solution of Ketorolac Tromethamine (4.2 µg/ml) and Phenylephrine Hydrochloride (12.6 µg/ml) was scanned separately in the range of 200-400 nm. From the overlay spectra of Ketorolac Tromethamine and Phenylephrine Hydrochloride, Absorbance correction method, Absorbance ratio and derivative spectroscopic International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 7, Issue 11, 2015 Innovare Academic Sciences