Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF BIMATOPROST AND TIMOLOL MALEATE

Janki A. Depani*, Ankit B. Chaudhary, Shweta M. Bhadani and Bhoomi D. Patel

ABSTRACT

A simple, precise, specific, accurate and robust Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed & validated as per ICH guideline Q2 R(1) for the simultaneous determination of Bimatoprost and Timolol Maleate. Chromatographic separation of these two drugs were carried out on C18 column of Inertsil (250 x 4.6 mm, 5 μm) as stationary phase with a mobile phase consisting of Phosphate buffer (pH 6.0 adjusted with 1 N NaOH): ACN (60:40 %v/v) at a flow rate of 1ml / min and UV detection at 210 nm. The retention time of Bimatoprost and Timolol Maleate were 6.357 min and 2.203 respectively. The proposed method was validated for specificity, linearity, accuracy, precision, LOD & LOQ. The describe method was linear over a concentration range of 5-15 μg/ml, 25-75 μg/ml for Bimatoprost and Timolol Maleate respectively. The % recoveries of Bimatoprost and Timolol Maleate were found 99.667% - 101.292% and 100.266% - 101.763% respectively. The optimized and validated method can be used for estimation of Bimatoprost and Timolol Maleate in bulk and also in finished product.

Keywords: Bimatoprost, Timolol Maleate, RP-HPLC, Validation, Finished product.