XÂY DỰNG QUY TRÌNH ĐỊNH LƯỢNG 8 HOẠT CHẤT TÂN DƯỢC NGỤY TẠO TRONG THUỐC DƯỢC LIỆU ĐIỀU TRỊ GIẢM ĐAU KHÁNG VIÊM BẰNG PHƯƠNG PHÁP HPLC-PDA

Abstract

Background: Currently, the illegal mixing of the Western pharmaceutical medicines into traditional medicines is complicated, especially in the treatment of chronic diseases such as osteoarthritis. In addition, there are no studies in Vietnam that determine meloxicam, a high-risk active ingredient that could be illegally blended with traditional herbal preparations. Objectives: A process to determine some fake Western drugs in anti-inflammatory and analgesic medicinal drugs method was developed by using HPLC-PDA. Methods: 8 APIs for pain and anti-inflammatory treatment: paracetamol, piroxicam, meloxicam, diclofenac sodium, ibuprofen, prednisolone, betamethasone and dexamethasone acetate. The placebo sample, chromatography conditions and extraction conditions was investigated. The process was validated according to AOAC guideline (2013). Results: The process of simultaneous quantification of 8 APIs was established as: column – XBridgeTM C18 (150 x 4,6 mm; 5 µm); moblie phase – mixture of acetonitrile and phosphoric acid pH 3,5 in gradient mode; flow rate – 1 ml/min; injection volume – 10 μl; column temperature – 30 °C and dectection – PDA (220 nm); the preparation of sample: extracting with 20 ml ethyl acetate by ultrasound in 10 mins and 2 times, eliminating impurities by SPE with 3 ml MeOH. The proposed procedure complied well all the requirements of AOAC guidelines (2016). There were 3/5 products containing paracetamol, piroxicam, diclofenac and betamethasone. Conclusions: A simultaneous quantitative process for 8 substances that illegally mixed into traditional herbal preparations for pain relief and anti-inflammatory treatment developed and applied successfully by HPLC-PDA.