Development and validation of a stability indicating UPLC method for determination of ticlopidine hydrochloride in its tablet formulation

• DOI: 10.1016/j.jsps.2011.03.005
• Publication Date: 2011-04-09T11:48:06Z
• Authors: Vijay Ram; Govind Kher; Kapil Dubal; Bhavesh Dodiya; Hitendra Joshi
• Keywords: Repeatability; Forced degradation; Accuracy and precision

The objective of the current study was development a simple, precise and accurate isocratic reversed-phase stability indicating Ultra Performance Liquid Chromatography [UPLC] assay method validated for determination ticlopidine hydrochloride in solid pharmaceutical dosage forms. Isocratic separation achieved on Zorbax SB-C18 (50 mm × 4.6 mm, 1.8 μm) column using mobile phase methanol-0.01 M ammonium acetate buffer, pH 5.0 (80:20, v/v) at flow rate 0.8 ml min(-1), injection volume 4.0 μl detection carried out 235 nm by photo-diode array detector. drug subjected to oxidation, hydrolysis, photolysis heat apply stress condition. specificity, linearity, precision, accuracy, robustness solution stability. linear concentration range 62.5-375 μg ml(-1) with correlation coefficient 0.9999. precision (relative standard deviation - RSD) six samples 1.31% repeatability intermediate [RSD] among six-sample preparation 0.77%. accuracy (recovery) between 98.80% 101.50%. Degradation products produced as result studies did not interfere can thus be considered indicating.