Estimationof Sitagliptin Phosphate monohydrate in presenceof itsdegradantsusingRP-HPLC

A simple, economic, selective, precise, and stability-indicating HPLC method has been developed and validated for estimation of Sitagliptin both in bulk drug and tablet dosage form. The drug was separated using a mobile phase acetonitrile: water, (5:95 v/v) on an Agilent, TC C18 (250 × 4.6 mm) 5µm column at flow rate of 1.0 mL min-1 at ambient temperature and detection was performed at 263 nm. The detector linearity was established in concentrations ranging from 10–80 µg mL−1, the regression coefficient was 0.9996. For stability study, the drug was exposed to the stress conditions such as acid, base, oxidation, neutral and sunlight as per the recommendations of ICH guidelines. The results of the analysis were validated in terms of specificity, limit of detection, limit of quantification, linearity, precision and accuracy. As per ICH guidelines results were found to be satisfactory. The method was proved to be robust with respect to changes in flow rate and temperature. The high recovery and low relative standard deviation confirm the suitability of these methods can be employed for the routine analysis of tablet containing Sitagliptin.

Author(s): Shubhangi C. Daswadkar, Sanjay G. Walodeand Mahendra Kumar C. B.

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