ABSTRACT

The current research aims to develop and validate a stability-indicating reversed phase-high performance liquid chromatographic method for the simultaneous estimation of Doxofylline and Ambroxol Hydrochloride. The specific objective is to create a method that is precise, accurate, and robust, suitable for use as a stability-indicating method for the simultaneous estimation of Doxofylline and Ambroxol Hydrochloride. The method development involved utilizing Chromatopak (250 x 4.6 mm, 5?m) with ACN: Potassium dihydrogen orthophosphate buffer pH 4.5 (pH adjusted with 1 percentage TEA) (70:30) as a mobile phase, detected by a photodiode array detector at a wavelength of 254 nm at a flow rate of 1 mL/min. In this study, Doxofylline and Ambroxol Hydrochloride were exposed to various stress conditions including acidic hydrolysis, basic hydrolysis, neutral hydrolysis, oxidation, thermal, and photolytic degradation. The percentage degradation was found to be within the range of 10-20 percentage. Linearity was observed in the range of 40-200 ?g/mL and 3-15 ?g/mL with correlation coefficients of 0.998 and 0.999 for Doxofylline and Ambroxol Hydrochloride, respectively. The percentage relative standard deviation of respective observations was found to be less than2 percentage. The developed method was successfully validated according to ICH guidelines for all parameters for analytical method validation. Keywords: Ambroxol Hydrochloride, Analytical Method Validation, Asthma, Chronic Obstructive Pulmonary Disease, Doxofylline, Stability indicating RP-HPLC method
Publication date: 01/04/2025

https://ijbpas.com/pdf/2025/April/MS_IJBPAS_2025_8774.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.4.8774