Force degradation study of butenafine hydrochloride in bulk and cream formulation

Author : Kaveri T. Vaditake, Charushila J. Bhangale, Anagha V. Baviskar and Vijay D. Wagh

Simple specific, accurate and precise UV-Spectrophotometric method is developed for Butenafine hydrochloride in bulk and cream formulation. The method has been validated for the linearity, accuracy, precision, robustness and ruggedness as per ICH guideline. The solvent used was methanol and the λ max or the absorption maxima of the drug was found to be 252 nm. The linearity for butenafine hydrochloride was found to be in the range of 10-60 g/ml with the regression coefficient of 0.999. Stability of butenafine hydrochloride was carried out by force degradation study. The stress degradation studies showed that Butenafine hydrochloride undergoes degradation in acidic, alkaline, dry heat, oxidation and photolytic conditions. This method can be used for the determination of Butenafine hydrochloride in quality control of formulation without interference of the excipients. All the above factors lead to the conclusion that the proposed method is accurate, precise, simple, sensitive, robust and cost effective and can be applied successfully for the estimation of butenafine hydrochloride in bulk and pharmaceutical formulation. The proposed method is also useful for determination of butenafine hydrochloride stability in sample of pharmaceutical dosage forms.

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