DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UV SPECTRO-PHOTOMETRIC METHOD FOR THE ESTIMATION OF BENZYDAMINE HYDROCHLORIDE IN BULK AND IN PHARMACEUTICAL DOSAGE FORM: A NOVEL ANALYTICAL TECHNIQUE FOR CONDUCTING IN-VITRO QUALITY CONTROL TESTSAbstract
The objective of the present study is to develop and validate a novel stability indicating UV spectrophotometric method for estimation of Benzydamine Hydrochloride (BNZ) in pharmaceutical dosage form as not a single UV spectrophotometric method has been reported for the estimation of Benzydamine Hydrochloride, which makes the present work novel. In the present research work, UV spectrophotometric determination was carried out at an absorption maximum of 305.6 nm in pH 6.8 phosphate buffer. The purposed method was validated statistically for linearity, accuracy, precision, repeatability, ruggedness, sensitivity as per International Conference on Harmonization guidelines. The drug substance was exposed to acid hydrolysis, alkaline hydrolysis, oxidative degradation, photolytic degradation, and thermal degradation and the stressed samples were analyzed by the proposed method to demonstrate the specificity of the method. The application of developed method was established by performing the assay of pharmaceutical formulation. The proposed method obeyed beer lambert’s law in the concentration range of 5 – 50 µg ml-1 with correlation coefficient (r2) of 0.999. Percentage relative standard deviation associated with all the validation parameters were ≤ 2%. There were no significant changes in absorbance after performing the forced degradation studies and the % age drug recovery was found to be 98.53% and 98.53% for film and gel respectively. The proposed method was found to be novel, simple, rapid, precise, selective, reproducible economical and stability indicating can be successfully applied to the determination of Benzydamine Hydrochloride in bulk and in pharmaceutical dosage form.