Chemometrics-assisted content uniformity evaluation of extemporaneous preparation containing ambroxol HCl, pseudoephedrine HCl, and triprolidine HCl

Abstract

Split powder preparations containing ambroxol HCl, pseudoephedrine HCl, and triprolidine HCl were frequently dispensed at a private hospital in Semarang, Central Java, Indonesia. Triprolidine HCl was reported to have a low composition in the divided powder. Content uniformity is one of the most important characteristics of extemporaneous formulations, especially for low-dose active ingredients. The aim of this study was to evaluate the dose uniformity of the divided powder preparation containing ambroxol HCl, pseudoephedrine HCl, and triprolidine HCl prepared by a pharmacist in a private hospital in Semarang, Central Java, Indonesia. In this study, the spectrophotometric method was used in combination with the chemometric analysis to determine the drug concentration in the divided powder. The accuracy of the models was evaluated by the highest value of the coefficient of determination of calibration, cross-validation and validation, while the precision of the models was evaluated by the lowest value of the mean square error of calibration, cross-validation and prediction. The selected model for each compound was used to build predictive models for quantitative analysis. It was found that the content of ambroxol HCl, pseudoephedrine HCl, and triprolidine HCl in the subdivided powder samples were 8.120 ± 1.167 mg, 30.142 ± 3.965 mg, and 1.193 ± 0.221 mg, respectively. The results on the uniformity of the content did not meet the requirements, as it was found that the coefficient of variance of these determinations was more than 5%. Surprisingly, the divided powder can be considered as a safe and acceptable dosage form due to its wide therapeutic window.