Stability Indicating RP -HPLC Method Development and validation for the simultaneous estimation of Ertugliflozin and Sitagliptin in Bulk and Pharmaceutical Dosage form
Keywords:RP-HPLC, Ertugliflozin, Sitagliptin, Method Development
A simple, Accurate, Precise method was developed for the simultaneous estimation of sitagliptin and ertugliflozin in tablet dosage form. Chromatogram was run through std zorbac C18 150x4.6 mm, 5 µ. Mobile phase containing buffer 0.01N Na2HPO4: Acetonitrile taken in the ratio 55:45 was pumped through column at flow rate of 1ml/min. Buffer used in this method was 0.01N Na2HPO4. Temperature was maintained at 30°C. Optimized wavelength selected was 265nm. Retention time of sitagliptin and ertugliflozin were found to be 2.156 min and 3.057 mins. %RSD of the sitagliptin and ertugliflozin were found to be 0.7 and 0.6 respectively. %Recovery was obtained as 101.06% and 99.03% for sitagliptin and ertugliflozin respectively. LOD, LOQ values obtained from regression equations of sitagliptin and ertugliflozin were 1.55,0.04 and 4071,0.12 respectively. Regression equation of sitagliptin is Y=20989x +10319 and Y=86906x +1104.2 of Ertugliflozin. Retention times were decreased and that rub time was decreased, so the method developed was simple and economical that can be adopted in regular quality control test in industries.
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