THE INFLUENCE OF GRINDING TIME AND EQUIPMENT ON THE HOMOGENEITY AND STABILITY OF DIVIDED POWDERS CONTAINING SALBUTAMOL SULPHATE AND AMBROXOL HYDROCHLORIDE

The prevalence of compounding divided powder remains high in pediatric patients due to the limitation of licensed drugs. Divided powder was compounded for easy dosage adjustment. Previous studies showed that the homogeneity of pulveres didn`t meet the requirement and was Beyond the Use Date of less than 30 days. The study aims to enhance the homogeneity and stability quality of divided powder compounding containing salbutamol sulphate and ambroxol hydrochloride. The process was carried out using mortar-pastle and pulverizer with 1, 3, and 5-minute grinding time. Determination of active substances using UV-spectrophotometer with PLSR and PCR chemometrics models with data preprocessing. Evaluation results from the most optimal chemometric model to determine the content. The best model was PCR, with the first derivative for ambroxol hydrochloride and the second derivative for salbutamol sulphate. The result of the compounding process didn`t meet the homogeneity test for 30 samples. The BUD of ambroxol hydrochloride was more than 1 month with a pulverizer and more than 4 months with a mortar pestle. Therefore, good recommendations for a divided powder compounding process can be made with a 1-minute grinding time with a pulverizer or mortar-pestle with 1 or 3 minutes grinding time.