J.V.L.N.Seshagiri Rao

The present study is a simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of Irbesartan and Atorvastatin from bulk and formulations. The proposed method was developed by HPLC Shimadzu Separation Module with PDA/UV detector connected to Empower-2 software using Inertsil C18 ODS (4.6 x 250mm, 5mm) with an injection volume of 20 µl was injected and eluted with a mobile phase composition of Methanol: Acetonitrile (50:50), which is pumped at a flow rate of 0.8ml/min and detected by PDA detector at 245nm. Ambient column temperature has maintained. The total run time was 10mins.The retention time of Irbesartan and Atorvastatin were found to be 2.9 min. and 4.1 min respectively. Linearity was observed in the concentration range of 0.2-0.8mg/ml for Irbesartan and Atorvastatin respectively with correlation coefficient 0.999 for both the drugs. Percent recoveries obtained for both the drugs were98.0-101.50%, respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed IRB be used for the routine analysis of Irbesartan and Atorvastatin from their combined dosage form.

A new simple, accurate, precise and reproducible Reverse Phase-High Performance Liquid Chromatography  method has been developed for the simultaneous estimation of Sitagliptin and Metformin in bulk and pharmaceutical dosage form using Symmetry C18 column (4.6 x 150mm, 3.5mm, Make: XTerra) in isocratic mode. The mobile phase has been prepared by using Potassium Dihydrogen Phosphate and Acetonitrile in different ratio at different pH. Several trials have been performed and it was found that ratio 0f 65:35 of Potassium Dihydrogen Phosphate and Acetonitrile respectively was shown a good peak at pH 5.8 which has been adjusted by using Sodium Hydroxide. The detection was carried out at 254 nm. The method was linear over the concentration range for Sitagliptin 10-30ppl and for Metformin 100-300ppm. The % recoveries of Sitagliptin and Metformin were found to be 99.1 to 100.6% and 98.8 to 100.7% respectively. The validation of method was carried out utilizing International Conference on Harmonization (ICH) guidelines. The described High Performance Liquid Chromatography method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form.