Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF SAXAGLIPTIN HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM

Md. Saiful Islam*, Md. Taleb Hossain, Sukalyan Kumar Kundu, Md. Abdul Halim, Md. Rafiquzzaman

ABSTRACT

A sensitive, accurate, rapid, cost effective and robust HPLC method was developed for the quantification of Saxagliptin Hydrochloride (SGH) with PDA detection. In this method; a reversed-phase C18 (250 × 4.6 mm internal diameter and 5 μm particle size) column with a mobile phase of phosphate buffer: acetonitrile (80:20; v/v) containing orthophosphoric acid (pH 2.70) at 1.0 mL/min flow rate was used to separate SGH with a detection of 210 nm. The retention time of SGH was obtained as 5.43±0.03 min. All necessary validation parameters and system suitability tests were carried out in detail. Linearity was obtained in the concentration range of 0.10–0.30 mg.mL-1 with a correlation coefficient (R2) of 0.999. The LOD and LOQ values were found as 9 μg.mLg.mL g.mL-1 and 27 μg.mLg.mL g.mL-1, respectively and recovery was 100.28%. The percentage of RSD values for repeatability and intermediate precision of the method was obtained as 0.630% and 0.529% which are within the limit of ICH guidelines (2005). The validated method applied for pharmaceutical tablet dosage formulation and the accuracy were found 99.96%. The above findings showed that the proposed method is simple, accurate, precise and robust enough and can be applied to estimate SGH in its bulk and tablet dosage form successfully.

Keywords: Saxagliptin Hydrochloride tablets, Potency, RP-HPLC, Method validation.