Analytical method development and validation of ambroxol hydrochloride by UV spectroscopy and forced degradation study and detection of stability.

Abstract

Aim: The aim is to develop simple validated analytical method for analysis of Ambroxol hydrochloride by UV Spectroscopy and to study the forced degradation and stress conditions have been used to detect the stability of Ambroxol hydrochloride. Method: Ambroxol hydrochloride was estimated at 306nm. Linearity range was found to be2-10mcg/ml. The correlation coefficient was found to be 0.99987. The molar absorptivity was found to be 3947 L mol/cm. The proposed method Sandell’s sensitivity was found to be 0.111111 µg cm-2/0.001AU. The limit of detection and limit of quantification were found to be 3.94210and 11.94577µg /ml respectively. The degradation behavior of Ambroxol hydrochloride was carried out as per the standard procedures and guidelines. Forced acid hydrolytic degradation, alkali degradation and oxidative degradation of Ambroxol hydrochloride was performed in bulk and solid oral formulation using 1N Hydrochloric acid and 0.1M Sodium hydroxide at room temperature in different time intervals such as 0mins,30mins, 60mins and 90mins. The resulting solutions were analyzed for content by UV spectrophotometry at the maximum absorption of 306 nm.. The assay value ofAmbroxol hydrochloride in bulk and formulation was calculated at different time intervals for intraday and interday experiments. Results and conclusion: The proposed method was successfully applied for the determination of Ambroxol hydrochloride in bulk and Pharmaceutical formulations (Tablets). The results were demonstrated, that the procedure is accurate, precise and reproducible (relative standard deviation < 2%), For acid degradation studies the assay values of Ambroxol hydrochloride at the end of the 90mins and 3rd day study for standard and sample were 58.42% and 50.53% respectively. For alkali degradation studies the assay values of Ambroxol hydrochloride at the end of the 90mins and 3rd day study for standard and sample were were 70.85% and 77.06% respectively. For oxidative degradation studies the assay values of Ambroxol hydrochloride at the end of the 90mins and 3rd day study for standard and sample were were 58.42% and 43.42% respectively. Ambroxol hydrochloride was found to degrade extensively under acid, alkali and oxidative conditions. Ambroxol hydrochloride has to be stored under such condition where the possibility of acid, alkali and oxidative hydrolysis does not arise.