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目的建立一种测定非诺贝特胆碱的胆碱部分含量的HPLC法。方法非诺贝特胆碱经3,5-DNB衍生后采用HPLC法测定。色谱柱为Diamonsil C_8(2)(250 mm×4.6 mm,5μm),流动相为乙腈-磷酸缓冲液(0.05 mol·L~(-1)Na_2HPO_4溶液,磷酸调pH至2.5)(30∶70),检测波长为208 nm,流速为1 m L·min~(-1),柱温为30℃。结果所建方法在15.25~61.03mg·L~(-1)内线性良好(R~2=0.999 9);回收率为98.04%~98.54%;精密度良好;衍生化产物在24 h内稳定;测定非诺贝特胆碱的胆碱部分相对含量为(100.82±0.64)%。结论所建方法快速、灵敏、准确、可靠,适用于非诺贝特胆碱的胆碱部分含量测定。
Objective To establish a method for the determination of fenofibrate choline part of the content of HPLC method. Methods Fenofibrate choline was derivatized with 3,5-DNB and determined by HPLC method. The chromatographic column was Diamonsil C_8 (2) (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-phosphoric acid buffer (0.05 mol·L -1 Na2HPO4 solution and phosphoric acid adjusted to pH 2.5) , The detection wavelength was 208 nm, the flow rate was 1 m L · min -1, and the column temperature was 30 ℃. Results The established method showed a good linearity (R ~ 2 = 0.999 9) within the range of 15.25 ~ 61.03 mg · L -1. The recovery was 98.04% ~ 98.54%. The precision was good. The derivatized product was stable within 24 h. Determination of fenofibrate choline part of the relative content of (100.82 ± 0.64)%. Conclusion The method was rapid, sensitive, accurate and reliable and suitable for determination of choline content in fenofibrate choline.