DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF NAPHAZOLINE HCL AND PHENYLEPHRINE HCL IN EYE DROPS

A first order derivative UV-spectrophotometric method was developed to quantify naphazoline hydrochloride and phenylephrine hydrochloride in eye drops. Naphazoline hydrochloride and phenylephrine hydrochloride were estimated at 275.6nm (zero crossover point of phenylephrine hydrochloride) and 289.4nm (zero crossover point of naphazoline hydrochloride), respectively. The method was found to be linear in the concentration range of 10 - 25 µg/ml for naphazoline hydrochloride and 20 - 60 µg/ml for phenylephrine hydrochloride. The developed method was subjected to validation in accordance with ICH guidelines Q2(R1) for different validation parameters. The analytical method developed was found to be accurate and cost - effective and can be used for routine analysis of naphazoline hydrochloride and phenylephrine hydrochloride in eye drops.