Forced degradation studies

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 simple, sensitive, accurate and precise high performance thin layer chromatographic method was developed and validated for simultaneous determination of efavirenz (EFA), emtricitabine (EMT) and tenofovir (TEN) in combined tablet formulation and forced degradation studies were performed as per ICH guidelines. Precoated silica gel 60F 254 was used as stationary phase and the mobile phase used was chloroform: methanol (90:10), gives high resolution for each drug. The densitometric evaluation of each drug was carried out at 262 nm. The developed method was simple, accurate and is suitable for analysis of the drugs and degradation products in stability studies of samples.