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Chromatographic determination of sitagliptin and simvastatin in their pharmaceutical formulation

Mamdouh R.Rezk, Sherif A.Abdel-Gawad

Two methods namely, coupled TLC densitometry and high performance liquid chromatography, were used to determine sitagliptin and simvastatin simultaneously in their pharmaceutical dosage form. A TLC separation with densitometric detection of both drugs was achieved using benzene: n-butanol: triethylamine (9:2:0.5, by volumes] as a developing solvent. Furthermore, a high performance liquid chromatographic procedure with ultraviolet detection at 220 nmwas developed for the separation and determination of the studied drugs using a C18 column. The mobile phase was composed of water: methanol: acetonitrile (1: 2: 2, by volumes). The final pH was adjusted to 4.6 ± 0.1 with O-phosphoric acid. The proposed methods were successfully applied for the determination of the studied drugs in pure forms, their mixtures and in pharmaceutical formulation containing them.