Simultaneous UV Spectrophotometric Method for Estimation of Sitagliptin Phosphate and Metformin Hydrochloride in Bulk and Tablet Dosage Form

Abstract

Two simple, precise and economical UV methods have been developed for the simultaneous estimation of Sitagliptinphosphate and Metformin hydrochloride in bulk and pharmaceutical dosage form. Method A is Absorbance maximamethod,whichisbasedonmeasurementofabsorptionatmaximumwavelengthof266nmand232nmforSitagliptinphosphateandMetforminhydrochloriderespectively.MethodBisareaundercurve(AUC),inthewavelength range of244-279 nm for Sitagliptin phosphateand222-240nm for Metformin hydrochloride. Linearityfordetector response wasobserved in the concentration range of25-225µg/ml for Sitagliptin phosphate and 2-12µg/ml for Metformin hydrochloride. The accuracy of the methods was assessed by recovery studies and was found tobe99.64%and98.98%forSitagliptinphosphateandMetforminhydrochloride.Thedevelopedmethodwasvalidatedwithrespecttolinearity,accuracy(recovery),precisionandspecificity.Theresultswerevalidatedstatistically as per ICH Q2 R1 guideline and were found to be satisfactory. The proposed methods were successfullyappliedforthedeterminationofforSitagliptinphosphateandMetforminhydrochlorideincommercialpharmaceuticaldosage form.