New analytical method development optimization and efficient validation by chemometric approach for marketed formulations

Abstract

Spectrophotometric methods are the oldest technique for the analysis of components. It have advantages of being simple, reproducible and fast; the apparatus is relatively cheap, still make the methods more attractive. The main disadvantage of spectrophotometric method is the simultaneous analysis of two or more active components in the same mixture was quite tough in resolving the overlapped bands. But this was overcome by new technique called spectrophotometric coupled with chemometrics. Multivariate calibrations methods are playing a very important role in the multi component analysis of mixtures. The approach is useful in the resolution of band overlapping in quantitative analysis. The multivariate calibration has been found to be the method of choice for complexed mixtures. The advantage of multi component analysis using multivariate calibration is the speed of the determination of the components in a mixture, avoiding a preliminary separation step. Control analyses on pharmaceutical preparations using multivariate calibration method, has been proved to be a valid alternative to HPLC. The application of quantitative chemometric methods, particularly principal component regression (PCR) and partial least square (PLS) to multivariate methods. PLS and PCR are calibration methods more effective for the resolution of mixtures having serious spectral overlapping and non-linear absorbance. The main advantage of a multivariate calibration when applied on spectral data is the high speed in processing both absorbance and concentration values. At the same time errors of calibration model are minimized by measuring the absorbances at many points in the wavelength range of the zero order and derivative spectra. The results obtained confirm the suitability of the proposed method for accurate and precise analysis of studied drugs. These methods were applied directly to the commercial mixture preparations without previous treatment. In addition the proposed methods are suitable for application without interference of the excipients.