Institute of Clinical Pharmacology, Department of Pharmacy, General Hospital of Ningxia Medical University, Ningxia, China; Ningxia Medical University School of Pharmacy, Ningxia, China.
Cancer Hospital, General Hospital of Ningxia Medical University, Ningxia, China.
J Chromatogr B Analyt Technol Biomed Life Sci. 2023 May 30;1224:123754. doi: 10.1016/j.jchromb.2023.123754. Epub 2023 May 15.
Pirarubicin (THP), doxorubicin (DOX), cyclophosphamide (CTX), and vincristine (VCR) are widely used in the treatment of patients with non-Hodgkin's Lymphoma. Herein, a precise and sensitive method was developed for the determination of THP, DOX, CTX and VCR in human plasma by high-performance liquid-chromatography-tandem mass spectrometry (LC-MS/MS). Liquid-liquid extraction was applied to extract THP, DOX, CTX, VCR, and the internal standard (IS, Pioglitazone) in plasma. Agilent Eclipse XDB-C18 (3.0 mm × 100 mm) was utilized and chromatographic separation was obtained in eight minutes. Mobile phases were composed of methanol and buffer (10 mM ammonium formate containing 0.1% formic acid). The method was linear within the concentration range of 1-500 ng/mL for THP, 2-1000 ng/mL for DOX, 2.5-1250 ng/mL for CTX, and 3-1500 ng/mL for VCR. The intra- and inter-day precisions of QC samples were found to be below 9.31 and 13.66%, and accuracy ranged from -0.2 to 9.07%, respectively. THP, DOX, CTX, VCR and the internal standard were stable in several conditions. Finally, this method was successfully utilized to simultaneously determine THP, DOX, CTX and VCR in human plasma of 15 patients with non-Hodgkin's Lymphoma after intravenous administration. Finally, the method was successfully employed in the clinical determination of THP, DOX, CTX, and VCR in patients with non-Hodgkin lymphoma after administration of RCHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) regimens.
吡柔比星（THP）、多柔比星（DOX）、环磷酰胺（CTX）和长春新碱（VCR）广泛用于治疗非霍奇金淋巴瘤患者。在此，建立了一种灵敏、准确的测定人血浆中 THP、DOX、CTX 和 VCR 的高效液相色谱-串联质谱法（LC-MS/MS）。采用液-液萃取法提取人血浆中的 THP、DOX、CTX、VCR 和内标（IS，吡格列酮）。采用 Agilent Eclipse XDB-C18（3.0mm×100mm）色谱柱，在 8 分钟内实现了色谱分离。流动相由甲醇和缓冲液（含 0.1%甲酸的 10mM 甲酸铵）组成。THP 的浓度在 1-500ng/mL 范围内、DOX 的浓度在 2-1000ng/mL 范围内、CTX 的浓度在 2.5-1250ng/mL 范围内、VCR 的浓度在 3-1500ng/mL 范围内呈线性关系。QC 样品的日内和日间精密度均低于 9.31%和 13.66%，准确度在-0.2%至 9.07%之间。THP、DOX、CTX、VCR 和内标在多种条件下均稳定。最后，该方法成功应用于 15 例非霍奇金淋巴瘤患者静脉注射后人血浆中 THP、DOX、CTX 和 VCR 的同时测定。最后，该方法成功应用于利妥昔单抗联合环磷酰胺、多柔比星、长春新碱和泼尼松（RCHOP）方案治疗非霍奇金淋巴瘤患者后 THP、DOX、CTX 和 VCR 的临床测定。
