Validated UV-Spectrophotometric Method for the Simultaneous Estimation of Pyridoxine Hydrochloride and Doxylamine Succinate in Bulk and in Pharmaceutical Dosage Form

A new, simple, accurate and sensitive UV ‐ Spectrophotometric absorbance correction method has been developed for simultaneous determination of Pyridoxine Hydrochloride and Doxylamine Succinate in bulk and in combined tablet dosage form using distilled water as a solvent. The wavelengths selected for the analysis were 260 nm and 324 nm. Both Pyridoxine hydrochloride and Doxylamine Succinate were linear over the concentration range of 5 - 40 µg/ ml and 10 - 60 µg/ ml of Doxylamine Succinate and Pyridoxine hydrochloride, respectively. The percentage recovery was found to be in the range of 99.15 ‐ 100.71% for Pyridoxine Hydrochloride and 99.30 ‐ 101.99% for Doxylamine Succinate. The %RSD for recovery studies was found to be 0.5484 and 0.9071 for Pyridoxine hydrochloride and Doxylamine Succinate, respectively for. The low %RSD of recovery studies indicated that there is no interference due to excipients used in formulation. The amount of PYRI and DOXY was found to be 100.92% ± 0.6961 and 101.05% ± 0.7965. Optical characteristics like slope, intercept, molar absorptivity, correlation coefficient, LOD and LOQ were calculated. The developed method was validated statistically by recovery studies as per ICH guidelines. The % RSD value was found to be less than 2. Thus the proposed method was simple, precise, rapid and accurate and can be successfully applied for routine quality control analysis of simultaneous determination of Pyridoxine Hydrochloride and Doxylamine Succinate in bulk and in combined tablet dosage form.

کلیدواژه ها:

Pyridoxine Hydrochloride ، Doxylamine Succinate ، Absorbance correction method ، Validation