Priyanka Gondhale-Karpe
Vishwakarma University (VU), India
Title: Assay development and Impurity profiling study of Ambroxol hydrochloride and Acetylcysteine used in the treatment of various chronic obstructive pulmonary diseases
Biography
Biography: Priyanka Gondhale-Karpe
Abstract
Statement of the Problem: Acetylcysteine and Ambroxol belongs to the class of drugs called 'mucolytic agents', primarily used to prevent and treat symptoms of chronic obstructive pulmonary diseases (COPD), such as coughing, wheezing and shortness of breath. COPD is a group of lung diseases that mainly include emphysema, pneumonia and chronic bronchitis. These two mucolytic agents help in thinning and loosening phlegm in lungs, windpipe, and nose to provide relief from respiratory problems like coughing, wheezing, and shortness of breath. Ambroxol is also an expectorant promotes mucus clearance, facilitates expectoration and eases productive cough, allowing patients to breathe freely and deeply promotes the secretion of sputum by the air passages. Acetylcysteine serves as a prodrug to L-cysteine, a precursor to the biologic antioxidant glutathione; the oxidized glutathione and S-nitrosoglutathione bind to the glutamate recognition site of the NMDA and AMPA receptors and mucolytic activity takes place. Findings: Precise RP-HPLC analytical method developed for the For the simultaneous estimation of Assay and Impurity profiling study determination of both assay and related substances in Ambroxol hydrochloride and Acetylcysteine tablet dosage form with gradient elution pattern having mobile phase A as buffer pH 3.0 and mobile phase B as an Acetonitrile at 1.0mL/min flow rate, using Inertsil ODS 3V column, 40°C column temperature and PDA detector with wavelength 230nm. The analytical method is validated as per ICH guidelines including its forced degradation studies. The method was found to be linear in the range of 0.2ppm to 2.5ppm with correlation coefficient 0.999. Accuracy performed at LOQ to 250% level and recovery was found to be in the range of 95% to 105%. Conclusion & Significance: The developed analytical method thus provides a safe, easy and reproducible solution for the stability studies and QC release testing for the estimation of assay and related substances.