Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ANALYTICAL METHOD FOR ESTIMATION OF ACEBROPHYLLINE AND ERDOSTEINE IN SYNTHETIC MIXTURE

Pandey Shivangi, Dr. Bhumi R. Patel*, Mr. Jaymin G. Patel, Ms. Pooja Soni, Mr. Ronak N. Patel, Dr. Divyakant A. Patel

Abstract

A simple, precise, and accurate stability indicating RP-HPLC method was developed for the estimation of Acebrophylline and Erdosteine in synthetic mixture. The quantification was carried out using Zorbax C18 column (250 mm x 4.6 mm x 5 μm) and mobile phase comprised of 0.1 % Formic acid: Phosphate Buffer pH 4.8: Methanol in proportion of 60:15:25% v/v. The Flow rate was adjusted to 1.0 mL/min and the effluent was monitored at 220 nm using PDA detector. The retention time of Acebrophylline and Erdosteine was found to be 19.807 min 8.907 min respectively. The methods were validated in terms of specificity, linearity, precision, and accuracy, limit of detection, limit of quantification and robustness. The percentage assay was found to be 100.206 % for Acebrophylline and 100.154 % for Erdosteine in RP-HPLC method. Acebrophylline and Erdosteine were subjected to stress condition like Acid, Base, Oxidative, Thermal & Photo condition. Acceptable range of degradation was observed in Acebrophylline and Erdosteine in all the condition. The degradation products were well resolved from the pure drug with significant differences in their retention time. Thus, the proposed method enables rapid quantification and simultaneous estimation of the Acebrophylline and Erdosteine drug without any interference of excipients. So, the developed and validated method can be used for routine analysis of Acebrophylline and Erdosteine in synthetic mixture.

Keywords: Acebrophylline, Erdosteine, RP-HPLC, Stability indicating, Validation.