Objective: The main objective of the present investigation is to develop a sustained-release (SR) formulation to optimize the postprandial elevation of glucose level in type 2 Diabetic subjects using combination therapy. In the present research work, bilayer sustained release formulation of metformin hydrochloride (MFH) and gliclazide (GLZ), based on monolithic-matrix technology was developed and evaluated. Methods: The formulations of metformin hydrochloride layer and gliclazide layer that contain polyox WSR coagulant and different viscosity grades of hydroxyl propyl methylcellulose (HPMC) as sustained-release matrix were prepared by direct compression and wet granulation method respectively. The bilayer tablets were prepared after carrying out the optimization of metformin layer and evaluated for various pre-compression and post-compression parameters. For the best formulation selected on basis of in vitro evaluation of tablets, Fourier-transform infrared spectroscopy (FT-IR) studies and comparison of in vitro dissolution profile of developed formulation with the innovator were performed. Results: Metformin hydrochloride and gliclazide showed sustained release of drug by diffusion mechanism and followed first-order kinetics. The best formulation of metformin hydrochloride (M7) and gliclazide (G8) show 99.93% and 99.65% of drug release in 24 h respectively. The similarity factor (f2) was 79.95 for metformin hydrochloride and 73.62 for gliclazide when compared with the innovator. Conclusion: The monolith diffusion-controlled bilayer tablets of metformin hydrochloride and gliclazide offer improved patient compliance and convenience with better postprandial hyperglycemic control with once-a-day dosing. The sustained release of the drug up to 24 h regulate antidiabetic activity round the clock with minimal side effects.

A new method has been established for the simultaneous estimation of Telmisartan and Atorvastatin calcium by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Telmisartan and Atorvastatin calcium by using boston ODS C18 column, flow rate was 1.0ml/min, mobile Phase consists of methanol:Acetonitrile:buffer in ratio of 35:25:40. Detection wave length was 235nm.The instrument used was SHIMADZU HPLC auto sampler. The retention time of Atorvastatin calcium and Telmisartan was found to be 2.350 and 3.490 minutes respectively. The analytical method was validated according to ICH guidelines (ICH Q2b). The correlation coefficient (r 2 ) was found to be 0.997 and 0.999 for Telmisartan and Atorvastatin calcium respectively. % mean recovery was found to be 100.943% and 100.576% for Telmisartan and Atorvastatin calcium respectively. %RSD for precision on replicate injection was 0.46 and 0.70 for Telmisartan and Atorvastatin calcium respectively. The validation study was found to be precise, robust, and repeatable.