Abstract

DEVELOPMENT AND VALIDATION OF A NEW ANALYTICAL FORCED DEGRADATION AND STABILITY INDICATING METHOD FOR THE ESTIMATION OF TICAGRELOR BY RP HPLC

*Keerthi K., Suhasini Koyyada, Dr. Sadia Naseem and Dr. Nasreen Sultana

ABSTRACT

A simple and selective stability indicating RP HPLC method is described for the determination of Ticagrelor dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of Phosphate buffer: Methanol (80:20 v/v), with detection of 240 nm. Linearity was observed in the range 75-150 μg /ml for Ticagrelor (r2 =0.994) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. Ticagrelor stock solution subjected to acid and alkali hydrolysis, chemical oxidation and dry heat degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.

Keywords: Ticagrelor, RP-HPLC, Method Development, Validation.