A Review On: Process Validation and Quality Parameters of Atorvastatin Calcium

Abstract

Atorvastatin is a selective competitive inhibitor of HMG CoA reductase. It reduces total cholesterol, low density lipoprotein (LDL). HMG CoA reductase catalyzes the HMG CoA to mevolanate, which is the limiting step in cholesterol biosynthesis. It also reduces the VLDL cholesterol and triglyceride. The present research work focused process validation for Atorvastatin 10 mg. Validation is best viewed as an impartment and integral part of cGMP. Validation is therefore one element of quality assurance programs associated with a particular process. Quality cannot be assured only by doing finished product testing and in process monitoring but it should be built into the manufacturing process. So, building of quality require a special attention to a few factors like selection of material, process design, control variables, in process control and finished product testing. In this study three initial batch of Atorvastatin Calcium with same amount, method, equipment & validation criteria were taken. Various critical parameters during identification, determination of sodium content, determination of volatile matter, enantiomeric purity by HPLC, bulk and tapped density stages were identified and evaluated as per validation protocol. The outcomes of the entire process indicate that process validation data provides a high degree of assurance that the manufacturing process will produce a product meeting its predetermined specification and quality attributes.