Abstract

ROBUST RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION FOR SELECTED ANTIDIABETIC DRUG IN PHARMACEUTICAL FORMULATION

R. Sathiyasundar*, P. Perumal, Annabalaji, M.S. Anupama, Sreelakshmi Ramani S., Sai Nandini M.

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Abstract

Fixed dose combination therapy widely acceptable for clinically, therefore need to develop a simple and rapid HPLC method for simultaneous estimation of sitagliptin and simvastatin in pharmaceutical formulation. A mobile phase consists of 0.1% Triethylamine/Methanol/Acetonitrile (60/10/30 v/v/v) and C18 (4.6x 150 mm, 5.0 μm) column used as a stationary phase. The flow rate of mobile phase 0.9 ml/min and measurement took ambient temperature at 252 nm as an isobestic point and overall runtime was 10 min. For formulation sample were extracted with mobile phase as a diluent. For formulation samples were validated as per the ICH guidelines. This method can be utilized in assay of marketed formulation, content uniformity, etc.

Keywords: Fixed dose combination, sitagliptin and simvastatin, pharmaceutical formulation, RP-HPLC.