Mon, 18 Dec 2017

Development and Validation of RP-HPLC Method for the Quantitation of Ticagrelor Using Box-Behnken Experimental Design

Rahul P. Chilbule1 and Rajendra B. Kakde1*

1.Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur- 33, Maharashtra, India


ABSTRACT

For determination of ticagrelor, a high performance stability indicating liquid chromatographic method was developed, validated and optimized for the determination of quality in any quality control laboratory. The drug was subjected to stress alkaline, acidic, oxidative, thermal, Neutral and photo-degradation and was found to hydrolyze in acidic, alkaline conditions as well as under oxidative stress. Ticagrelor with the interferents are separated on a reversed phase Cosmosil (R) 5C8-MS (5 μm, 250 mm × 4.6 id) column using acetonitrile: 35 mM ammonium acetate buffer (pH 3.8) in the ratio of 40:60 as mobile phase at a flow rate of 1 ml min-1. The drug was detected at 254 nm over a concentration range of 5–140 μg ml−1 with mean percentage recovery 100.08% using a PDA detector. The method was validated and a 32 factorial was employed by using Box–Behnken experimental design for the validation of robustness. These designs have three factors such as mobile phase composition, flow rate and pH while peak area and retention time were taken as a response. This showed that little changes in the mobile phase and flow rate affect the response while pH has no effect. The compilation of precision result shows % RSD for system precision, and method precision is 0.4. The developed method was found to be precise, accurate, linear, robust and rugged. This method was successfully applied for the assay of commercially market tablet formulation; hence it can be adopted for the determination of quality in any quality control laboratory.

Keywords: Ticagrelor, Stability-indication methods, Linear regression analysis, Design of experiment


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