Abstract

DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR ESTIMATION OF SITAGLIPTIN IN THE TABLET DOSAGE FORM

Sammi Akter*, Md. Taleb Hossain, Arghya Prosun Sarkar, Md. Sadikuzzaman, Bidduth Kumar Sarkar, Pijus Saha and Sukalyan Kumar Kundu

ABSTRACT

An accurate, precise and cost effective HPLC method was developed that is not appeared in pharmacopoeia for estimation of Sitagliptin. Separation of the drug was achieved on a C18 column using a mobile phase consisting of phosphate buffer and acetonitrile in the ratio of 60: 40 (v/v). The flow rate was 1mL/min and detection wavelength was 254 nm. The linearity was observed in the concentration of 0.05, 0.20, 0.22, 0.25, 0.27, 0.29 mg/mL with a correlation coefficient (R2) of 0.999. The retention time of Sitagliptin was 5.2±0.03 min. The proposed method was validated as per the ICH guidelines for the parameters: Linearity, Accuracy, Precision, Robustness, and Specificity etc. This method can be employed for routine quality control analysis of Sitagliptin in tablet dosage form.

Keywords: Sitagliptin tablets, Potency, HPLC, Method validation.