Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF OLOPATADINE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Zeba Mahamad Hanif Gaibu*, Dr. Mallinath Shankarappa Kalshetti, Shubhangi Sidram Bamgonde, Kaveri Chandrakant Dulange, Neha Ranjeet Gate

ABSTRACT

A simple, precise, accurate, economical and reliable UV spectrophotometric method has been developed for the estimation of Olopatadine hydrochloride in bulk and its tablet dosage form. The drug shows maximum absorption (λmax) at 231 nm in methanol and obeys Beer’s law in the concentration range of 3-15 μg/ml with correlation coefficient (R2=0.999). The accuracy was found to be 97.2-99.6%. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.047 μg/ml and 0.144 μg/ml respectively. The relative standard deviation was found to be <2.0%in all cases. The proposed spectrophotometric method was validated as per ICH Q2 (R1) guidelines. Statistical analysis proved that the method is repeatable and specific for the determination of the said drug. The proposed method can be used for the reliable quantification of Olopatadine hydrochloride in bulk form and routine analysis of pharmaceutical formulations.

Keywords: Olopatadine hydrochloride, UV Spectrophotometer, Method Validation.