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目的建立HPLC法测定人血浆中奥沙普秦(oxaprozin,Oxa)浓度的方法,并研究其在健康受试者体内的药物动力学。方法采用固相萃取法提取样品,以布洛芬为内标物,采用Diamonsil-C18(150 mm×4.6 mm,5μm)色谱柱,流动相为甲醇-20 mmol·L-1醋酸铵水溶液(pH=3.0±0.2)(体积比为63∶27),流速为1.0 mL·min-1,柱温为30℃,检测波长为280 nm。结果 Oxa在0.5~150.0 mg·L-1内与峰面积呈良好线性关系(r=0.996 9),日间和日内精密度RSD均小于6.5%,提取回收率大于68.4%。主要药物动力学参数为:ρmax(84±12)mg·L-1,tmax(3.2±1.4)h,t1/2(49±4)h,AUC0→t(2 383±327)mg·h·L-1,AUC0→∞(2 468±346)mg·h·L-1。结论 HPLC法适用于临床测定奥沙普秦在人体中的浓度。
OBJECTIVE To establish a HPLC method for the determination of oxaprozin (Oxa) in human plasma and to study its pharmacokinetics in healthy volunteers. Methods The samples were extracted by solid-phase extraction. Diamonsil-C18 (150 mm × 4.6 mm, 5 μm) column with ibuprofen as the internal standard was used. The mobile phase was methanol-20 mmol·L-1 ammonium acetate aqueous solution = 3.0 ± 0.2) (volume ratio was 63:27), the flow rate was 1.0 mL · min-1, the column temperature was 30 ℃ and the detection wavelength was 280 nm. Results Oxa had a good linear relationship with the peak area in the range of 0.5-150.0 mg · L-1 (r = 0.996 9). The RSDs were less than 6.5% and the extraction recovery was more than 68.4% during the day and the day. The main pharmacokinetic parameters were ρmax (84 ± 12) mg · L-1, tmax (3.2 ± 1.4) h, t1 / 2 (49 ± 4) h and AUC0 → t (2 383 ± 327) mg · h · L-1, AUC0 → ∞ (2 468 ± 346) mg · h · L-1. Conclusion HPLC method is suitable for the clinical determination of oxaprozin in human body.