Study on the Quality Control for Self-microemulsifying Granule of Brucea Javanica Oil

Abstract:

Objective: To establish the methods of quality control for self-microemulsifying granule of Brucea Javanica Oil. Method: According to Chinese Pharmacopoeia, the quality of preparation was estimated. The HPLC method was used to determine the content of oleic acid and linoleic acid. The product was analyzed by HPLC, using Venusil XBP-NH₂column (4.6 mm×250 mm, 5 μm), with methanol-water (95:5) as the mobile phase, the flow rate of 1.0 mL·min^-1 and the detection wavelength of 242 nm. Result: The quality of preparation accorded with Chinese Pharmacopoeia regulation. The calibration curve showed good linearity over the range of 0.004 362-0.043 62 g·L^-1 for oleic acid;the average recovery was 98.04%. The calibration curve showed good linearity over the range of 0.000 912-0.009 14 g·L^-1 for linoleic acid;the average recovery was 101.60%. The content method is convenient, accurate and reduplicative. Conclusion: TLC and HPLC methods are simple, accurate and fast, which could be used effectively for the quality control of self-microemulsifying granule of Brucea Javanica Oil.