ABSTRACT
Objectives
The investigation article intends is to build and validate a more convenient scientific approach to accurately simultaneously determine famotidine and para-amino benzoic acid from their cocrystals
Significance
The zero-order spectra of both drugs demonstrated significant overlap between the two spectra curves; therefore, the simultaneous estimation of two drugs by zero-order spectra method was not feasible. Therefore, to overcome this and facilitate simultaneous analysis of both the therapeutic agent derivative spectrophotometry technique was employed; The sensitivity and selectivity of both the drug mixtures were enhanced by the derivative spectrophotometry technique.
Materials and Methods
First-order derivative spectra were chosen for the quantitative analysis of FMT and PABA in cocrystals. Zero-crossing measurements (both calculated and plotted) were employed to select the wavelength for each drug to carry out quality control analysis. ICH guidelines were referred to validate the technique.
Results
The wavelength 275 nm for FMT was selected referring to zero-crossing points (∆A/∆γ of PABA is zero at 275 nm) and 285 nm was selected for PABA (∆A/∆γ of FMT is zero at 285 nm) and no mutual intrusion was detected and these wavelengths were designated for estimation of these therapeutic agents. The linearity, accuracy, precision, and robustness of the method were validated by satisfying the statistical parameters.
Conclusion
The technique established for the simultaneous assessment of drugs (FMT and PABA) from cocrystals by first-order derivative spectrophotometric technique was validated. The development of the analytical method was reliable, economical, convenient, and environmentally friendly.