ABSTRACT

Two robust and scientifically sound diffuse reflectance Fourier transform infrared spectroscopic methods were developed for quantitative estimation of two novel drugs, capecitabine and cinacalcet hydrochloride, in drug substance and tablet dosage forms. Influence of method variables was investigated using the novel concept of analytical procedure development. Risk-based studies and designed chemometric experiments were found helpful for earmarking risky variables affecting the analytical method attribute. The number of scans and resolution were the two critical method variables affecting the absorbance of infrared radiation by the analyte. Quantitative measurements were performed at 1047cm-1 and 1070 cm-1 for capecitabine and cinacalcet, respectively. The experimentation involved rapid measurements at respective characteristic regions by direct mixing of the analyte with KBr. These methods were applied successfully to quantify novel drugs candidates in their in-house tablet formulations. Further, the newly developed methods were validated as per International Conference on Harmonization guidelines.