Nghiên cứu xây dựng quy trình định tính, định lượng diosmectit trong hỗn dịch thuốc bằng phương pháp phổ nhiêu xạ tia X và phân tích khối lượng

Abstract

An X-Ray diffraction method was developed for identification of diosmectite was developed by comparison of the analyzed spectrum with that of the authentic diosmectite. Diosmectite was gravimetrically quantitated after calcination of excipients, namely the total amount of the drug products in the tested oral suspensions. The method was validated in terms of the ICH Q2A requirements and in observance to the ICHguidelines. The linearity was good at the range of 1.8 - 4.2 g (r> 0.999); RSD of intra-and inter-day precisionvariations <2.0 %; mean recovery was (100.01 ± 0.21)% (RSD - 0.28%). For quantitative purpose, the method proved adequate and applicable to quality control of diosmectite in oral suspensions.