Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF BRIMONIDINE TARTRATE AND TIMOLOL MALEATE IN COMBINED OPHTHALMIC DOSAGE FORM

Vinayaka D.G*, Satishkumar Shetty A, Manzoor Ahmed, Anil Kumar S.M. Vijaya Krishna C.Aradhya, Siddalinga Swamy M.S.

ABSTRACT

The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method and subsequently validate as per ICH guidelines for the determination of Brimonidine tartrate (BRT) and Timolol maleate (TIM) using mobile phase [A mixture of Phosphate buffer- pH-3.6 and acetonitrile in the ratio of 70:30 was considered to be the optimal composition] as the solvent. The proposed method involves the measurement of retention time at selected analytical wavelength. 295.0 nm was selected as the analytical wavelength. The retention time of BRT and TIM was found to be 3.157 and 3.961 respectively. The linearity of the proposed method was investigated in the range of 4-20 μg/ml (r = 0.9999) for BRT and 10-50 μg/ml (r = 0.9998) for TIM respectively. The method was statistically validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less % RSD (Relative Standard Deviation) value indicating high grade of precision of the method.

Keywords: RP-HPLC method, Brimonidine tartrate, Timolol maleate, Validation.