UV-spectroscopic method development and validation for simultaneous estimation of doxylamine succinate and pyridoxine hydrochloride in bulk and pharmaceutical dosage form

Simple and precise UV-spectrophotometric methods were developed and validated for the simultaneous estimation of combined dosage form containing Doxylamine succinate and Pyridoxine HCl. A combination of these drugs is being used in the treatment of morning sickness associated with pregnancy. In the current study, both the drugs estimated by simultaneous equation and Q-absorbance ratio methods with the help of 260 and 290 nm as maximum absorption wavelengths, respectively for Doxylamine succinate and Pyridoxine HCl. Linearity was achieved at the concentration of 10-35 μg/mL for both drugs with correlation coefficient (r²) of 0.9949 and 0.9935, respectively. The % RSD for accuracy and precision were lies within the acceptance criteria. The percentage (%) recoveries found for both drugs were in the potency range (98.14-100.5 %). There was good agreement in results obtained for detection and quantitation limits studies which revealed the presence of sensitivity of the methods. The assay of the commercial sample was in well fit with the standards and the developed methods can allow for usual analysis of both drugs in combined dosage forms.