Method Development and Validation of Newer Analytical Methods of Drugs

Abstract

Newer analytical methods are developed for the drugs or drug combinations due to the patient must receive the good quality of drugs. The first goal of this research work was developed an accurate, precise and rapid method for the estimation of the Riluzole, because it is not official in any Pharmacopoeia. Derivative spectrophotometric method showed low percentage RSD values. The spectrophotometric method is found to be economical when compared to HPTLC method. The percentage RSD values in the quantification and recovery studies suggest that the excipients do not interfere in the analysis of the formulation and all the methods are accurate. HPTLC method is found to be more sensitive than the other methods because of its linearity range, LOD and LOQ were less in HPTLC method. The second goal was developed with a multi-component formulations have gained a lot of importance now a days due to greater patient acceptability, increased potency and decreased side effects of hypertension. Various simultaneous estimation methods which are employed for the quantitative estimation of drugs. By comparing spectrophotometric methods and HPTLC method of Olmesartan medoxomil, Amlodipine besylate and Hydrochlorothiazide drug combination, Graphical absorption correction method which shows low percentage RSD values while compared with other methods. But HPTLC method showed good sensitivity. The third goal was achieved with new drug combination of Emtricitabine, Rilpivirine hydrochloride and Tenofovir disoproxil fumarate which is indicated as a complete regimen for the treatment of HIV-1 infection in treatment-naive adults. A literature search may not reveal an analytical procedure for the drug or it combinations. While comparing with my developed methods, derivative spectrophotometric method shows low percentage RSD values. But HPTLC method shows good linearity and sensitivity. With the regard of outcome of the results, that all the methods can be applied successfully for the routine quality control analysis of the drugs in bulk.