Tuesday , 23 May 2017

Analytical Method Development and Validation for the Simultaneous Estimation of Brinzolamide and Timolol Maleate by RP-HPLC Method in Bulk and Tablet Dosage Form

CH. Shankar*, Punna Venkateshwarlu
Department of Pharmaceutical Analysis, Vikas College of Pharmaceutical Sciences, Rayanigudem, Suryapet, Nalgonda, Telangana, India-508376

A B S T R A C T
The chromatographic conditions were successfully developed for the separation of Brinzolamide and Timolol Maleate by using C18  Column (150mm x 4.6mm)5 µm, flow rate was 1 ml/min, mobile phase ratio was Methanol: Phosphate buffer PH 4.0 (70:30 v/v), detection wavelength was 260 nm. The Spectroscopic method was done in solvent using methanol and the instrument lab India 3000+ with UV win software. The instrument used was WATERS HPLC Auto Sampler, Separation module 2690, photo diode array detector, Empower-software version 2. The retention times were found to be 2.137 min and 2.844 min. The % purity of Brinzolamide and Timolol Maleate was found to be 99.86% and 100.1% respectively. The system suitability parameters for Brinzolamide and Timolol Maleate such as theoretical plates and tailing factor were found to be 5742, 1.4 and 5167 and 1.2. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Brinzolamide and Timolol Maleate was found in concentration range of 5µg-25µg and 20µg-100µg and correlation coefficient (r2) was found to be 0.999 and 0.999 respectively, % recovery was found to be 99.86% and 99.96% respectively. %RSD for repeatability and precision was found to be <2.LOD values were 0.021 and 0.025 and LOQ value was 0.025 respectively for Brinzolamide and Timolol Maleate.
Keywords: Brinzolamide, Timolol Maleate, HPLC.

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