Method development and validation of newer analytical methods as per ICH Guidelines

Abstract

Method validation is the way to authenticate that the analytical procedure applied for a specific test is appropriate for its intended purpose. Methods need to be validated or revalidated. newlineThe International Conference of Harmonization (ICH) of technical requirements for the registration of pharmaceutical for human use has developed and provided a consensus text on validation of analytical procedures. The proposed analytical methods are simple, accurate and reproducible. The advantages lie in the simplicity of sample preparation and the cost economic reagents used. The contribution is the limit of detection for all the methods. Results from statistical analysis of the experimental results for all the methods were indicative of satisfactory precision and reproducibility. Hence the spectrophotometric methods and HPLC method can be used for analysis of the different solid dosage formulations in commercial quality control laboratories. All the above methods do not suffer from any interference due to common excipients. Therefore it was shown that the proposed methods could be successfully applied to estimate the commercial pharmaceutical products containing Doxofylline and Ambroxol Hydrochloride, Metolazone and Spironolactone, Metoprolol and Olmesartan and Aspirin and Rosuvastatin. Thus the above studies findings would be helpful to the analytical chemists to apply the analytical methods for the routine analysis of the analytes in pharmaceutical dosage forms after their approval from FDA. However the following aspects of the method may also be tried for future analysis: newline1. HPTLC for formulation. newline2. Gas Chromotragraphic analysis. newline3. Liquid Chromatography Coupled to Tandem Mass Spectrometry. newline4. High Performance Liquid Chromatography with Fluorescence Detection. newline5. Colorimetric method development. newline6. In the presence of another drug. newlineThis study also paves the platform for the estimation of analytes in biological fluids.