Method Development and Validation for Simultaneous Analysis of Drug Molecules in Biological Samples

Abstract

Pharmacological properties in several bio-active molecules are well known and these molecules are administered to patient in form of pharmaceutical formulations. The most important pre-requisite for development of any pharmaceutical formulation is to have robust analytical methods for evaluation of active molecule content required for treatment of diseases and to evaluate its bio-availability/bio-equivalence in formulations targeting a site of action in human body. Therefore, development and validation of analytical methods plays important role in the drug discovery and development process. Having single and robust analytical method for simultaneous determination of multiple molecules had significant impact on cost of formulation development, routine analysis, time and resources consumption. newline newlinePioglitazone, a thiazolidinedione, is being recommended to treat of type 2 diabetes mellitus (T2DM) individually or along with other categories of anti-diabetic agents. Glimepiride belongs to class of 2nd generation sulfonylureas and is proved to treat T2DM. Numerous clinical studies had demonstrated the high-level effectiveness of fixed dose combinations of PIO and GLIME to reduce the level of sugar in blood and treatment of T2DM. This combination is more effective and beneficial than a monotherapy. An extensive literature review has been performed on the previous work done for development and validation of bioanalytical method for the simultaneous quantification from plasma samples for glimepiride and pioglitazone. Many methods of HPLC-MS were developed on the estimation for glimepiride and pioglitazone individually or with other drugs. The individual methods require processing of samples in two sets, different columns and parameters which has huge impact on resources, cost and time consumption. . The method proposed in this thesis can determine both the analytes simultaneously from single sample and single injection which reduces 50 % consumption.