THE COMPARATIVE ANALYTICAL METHOD DEVELOPMENT STUDY OF GENERIC VS BRANDED DRUGS

Abstract

The current goal of the project is to build a comparative analytical methodology for studying generic versus branded medications utilizing various brands, such as Micardis. By using the system's 0.98-m axial resolution to discriminate between GSK's branded Panadol tablets and generic paracetamol using UHROCT apparatus, we were able to demonstrate its usefulness and capacity. The method employed in this study demonstrates how FMEA may be used to screen possible variables for PBD study in order to reduce the overall number of tests carried out for the development of analytical methods. For the estimation of the above mentioned anti-cancer drugs (Imtanib Mesylate, Nilotinib, Dasatinib) in pharmaceutical dosage forms, human plasma, rabbit plasma, serum, urine, culture medium, cell preparations, etc., sensitive and accurate RP-HPLC methods, stability-indicating HPLC, HPLC-PDA, HPLC-UV, stability-indicating HPTLC and HPLC-MS, and solid phase extraction methods were developed. It is evident from this work that it is feasible to create a novel sensitive and precise HPLC approach for anti-cancer medications. Regular testing of generic medicinal items can greatly benefit from the use of UPLC technology, which can boost sample throughput and reduce solvent use (and eventual disposal). The systematic procedures described in this work will be useful for streamlining the production of generic AmpB liposomal formulations and verifying the similarity between generic and reference goods.