The Development and Validation of a new HPLC Method for the Simultaneous Determination of Impurities in Guaifenesin, Terbutaline Sulfate and Ambroxol Hydrochloride

A new liquid chromatography method was developed and applied for the simultaneous determination of Ambroxol Hydrochloride (AH), Guaifenesin (GN) and Terbutaline Sulfate (TS), which are present in raw materials with potential impurities in drugs and pharmaceutical products. This method uses YMC Triart C18 chromatography column. A gradient mixture of solvents A and B is used as the mobile phase, and a UV (ultraviolet) detector is used to detect at 210 nm. The column temperature is 50°C chromatographic separation resolution. TS, GN, AH and their impurities are more than 1.5. Regression analysis showed a high correlation coefficient (r> 0.998), indicating the reliability of the method. The developed method is capable of identifying 0.625% of impurities in test solution, GN and AH & TS based on the standard measurement of 1.0 mg/mL, 0.4 mg/mL and 0.025 mg/mL respectively. The model showed excellent inter-day and intra-day precision with percentage RSD values less than 3.0 for all impurities in TS, GN and AH. The process also shows that there is a recovery. Moreover, these chemicals are exposed to stresses such as acid, alkali, aqueous hydrolysis, oxidation, photolysis and thermal degradation according to the guidelines developed by the International Conference on Harmonization (ICH). Liquid Chromatography method provides a robust, sensitive and reliable method for the determination of TS, GN and AH and their impurities in pharmaceutical preparations.