卵巢癌患者奥拉帕尼的高效液相色谱-紫外检测方法的建立。

IF 1.9 Q3 PHARMACOLOGY & PHARMACY Drug Discoveries and Therapeutics Pub Date : 2024-01-12 Epub Date: 2023-12-03 DOI:10.5582/ddt.2023.01074
Takeo Yasu, Ryosuke Nishijima, Risa Ikuta, Mikio Shirota, Haruko Iwase
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引用次数: 0

摘要

奥拉帕尼(Olaparib)是一种小分子聚(ADP)-核糖聚合酶(PARP)抑制剂,用于卵巢癌复发和新诊断的晚期卵巢癌初始化疗后的维持治疗。有报道称,与奥拉帕尼相关的常见不良事件——贫血的概率与稳态最低血浆浓度(Cmin)以及预测最高血浆浓度(Cmax)之间存在暴露-毒性相关性。另一方面,奥拉帕尼在浓度-时间曲线下的面积、Cmax和Cmin方面表现出很高的患者间变异性。为此,建立了一种简便、灵敏的紫外高效液相色谱(HPLC-UV)检测奥拉帕尼治疗药物的方法。色谱柱为十八烷基硅基柱,流动相为0.5% KH2PO4 (pH 4.5)和乙腈(71:29,v/v),流速为0.8 mL/min。奥拉帕尼与内标(伊马替尼)分离较好,保留时间分别为13.6 min和11.5 min。奥拉帕尼在0.10 ~ 10.0 μg/mL范围内线性良好(r2 = 0.9998)。日内验证系数为1.79 ~ 4.13%,日内验证系数为1.37 ~ 3.55%。测定准确度为- 6.07 ~ 3.26%,回收率大于91.06%。然后应用该方法评价卵巢癌患者血浆奥拉帕尼浓度。本研究结果表明,高效液相色谱-紫外分光光度法是一种经济、简便、灵敏的临床应用方法,有望用于卵巢癌治疗期间奥拉帕尼的有效药物监测。
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Development of a simple high-performance liquid chromatography-ultraviolet detection method for olaparib in patients with ovarian cancer.

Olaparib is a small-molecule inhibitor of poly(ADP)-ribose polymerase (PARP) used as maintenance therapy for recurrent ovarian cancer and newly diagnosed advanced ovarian cancer after initial chemotherapy. An exposure-toxicity correlation has been reported between the probability of anemia, a common adverse event associated with olaparib, and the steady-state minimum plasma concentration (Cmin) as well as the predicted maximum plasma concentration (Cmax). On the other hand, olaparib exhibits high interpatient variability with regard to the area under the concentration-time curve, Cmax, and Cmin. Therefore, we developed a simple and sensitive assay based on high-performance liquid chromatography with ultraviolet light (HPLC-UV) for the therapeutic drug monitoring of olaparib. The analysis was performed on an octadecylsilyl column with a mobile phase consisting of 0.5% KH2PO4 (pH 4.5) and acetonitrile (71:29, v/v), at a flow rate of 0.8 mL/min. Olaparib and an internal standard (imatinib) were well separated from the co-extracted material, with retention times of 13.6 and 11.5 min, respectively. The calibration curve for olaparib showed linearity over the concentration range of 0.10-10.0 μg/mL (r2 = 0.9998). The intra- and inter- day validation coefficients ranged from 1.79 to 4.13% and 1.37 to 3.55%, respectively. Measurement accuracy ranged from - 6.07 to 3.26%, with a recovery rate of more than 91.06%. The developed method was then applied to evaluate the plasma olaparib concentrations in patients with ovarian cancer. Our findings demonstrate that HPLC-UV is an economical, simple, and sensitive method for clinical application and holds promise for the effective drug monitoring of olaparib during ovarian cancer treatment.

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来源期刊
Drug Discoveries and Therapeutics
Drug Discoveries and Therapeutics PHARMACOLOGY & PHARMACY-
CiteScore
3.20
自引率
3.20%
发文量
51
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