Method Development and Validation of Assay of Pyridoxine Hydrochloride and Doxylamine Succinate

S. Masoom Vali*, G. Somasekhar, Y. Suresh, Haniffa Bee S, K. Suresh
Department of Pharmaceutical Analysis, SAFA College of Pharmacy, Kurnool, Andhra Pradesh, India

A B S T R A C T
A new method was established for simultaneous estimation of Pyridoxine hydrochloride and Doxylamine succinate by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Pyridoxine hydrochloride and Doxylamine succinate by using Zorbax Bonus RP (150×4.6) mm, 5µ (Manufacturer: Agilant column, flow rate was 1.0ml/min, detection wave length was 272nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2.The retention times were found to be 2.6 mins and 4.9mins. From the developed method it was found that both Pyridoxine HCl and Doxylamine Succinate obey linearity within the concentration range of 2.5-15 mg/ml. From the results of precision and intermediate precision it was found that the % RSD is less than 2, which indicates that the method has good reproducibility. From the results shown in accuracy it was found that the percentage recovery values of formulation from the placebo solution were in between 98.0– 102.0 which indicates that the proposed method is accurate and also reveals that the commonly used excipients and additives in the pharmaceutical formulations were not interfering in the proposed method. From the results of Robustness it was found that a little variation in methods does not affect the intended use. From the results of Forced degradation studies it was found that method is fit to use stability studies.
Keywords: Pyridoxine hydrochloride, Doxylamine succinate, HPLC