DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS DETERMINATION OF PREDNISOLONE ACETATE AND OFLOXACIN IN EYE-DROPAbstract
The present manuscript describes simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for the simultaneous determination of prednisolone acetate and ofloxacin in combined eye drop dosage form. The method is based on the simultaneous equations method for analysis of both the drugs using methanol as solvent. Prednisolone acetate has absorbance maxima at 243 nm and ofloxacin has absorbance maxima at 228 nm in methanol. The linearity was obtained in the concentration range of 5-17 μg/ ml and 1-13 μg/ml for prednisolone acetate and ofloxacin respectively. The concentrations of the drugs were determined by using simultaneous equations method at both the wavelength set 243nm for PRD and 228nm for OFL. The method was successfully applied to pharmaceutical dosage form because no interference from the eye-drop excipients was found. The suitability of this method for the quantitative determination of prednisolone acetate and ofloxacin was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of prednisolone acetate and ofloxacin in pharmaceutical dosage form. The result of analysis has been validated statistically and by recovery studies.
H.N. Barot*, J.B. Dave and C.N. Patel
Department of Quality Assurance, Shri Sarvajanik Pharmacy College, Nr. Arvind Baug, Mehsana-384001, Gujarat, India
24 February, 2012
21 March, 2012
25 May, 2012
01 June, 2012