Validated HPTLC method for simultaneous estimation of sitagliptinphosphate and simvastatin in tablet dosage form

摘要

A novel, simple, sensitive, rapid, accurate and suitable High performance thin layer chromatographic method was developed for the determination of Simvastatin (SIM) and Sitagliptin phosphate (SITA) in bulk and tablet dosage form. A TLC – spectrodensitometric method was developed by the separation of SIM and SIT on silica gel 60F 254 using a mobile phase mixture of Toluene, Methanol and Acetic acid in a ratio of 5:4:1 v/v/v as a developing system, followed by spectro densitometric measurement of the bands at 255 nm. The Rf values for both the drugs were found to be 0.5241 for SITA and 0.7865 for SIM respectively. Calibration curve was linear over the concentration range of 100-500 ng/ml for Sitagliptin phosphate and 40 – 200 ng/ml for Simvastatin. The suggested method was validated in compliance with the ICH guidelines parameters like Linearity, specificity, precision, accuracy, robustness and ruggedness. The percentage RSD values were found to be 0.22182 for SIM and 0.424151 for SITA respectively. The percentage purity of SIM were found to be 99.78 ± 0.632712 and for SITA 99.9830 ± 0.175357. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug and dosage form.