Du Ping, Li Pengfei, Zhao Rui, Liu Hongchuan, Liu Lihong
Beijing Chao-Yang Hospital, Capital Medical University, No. 8 Gongti South Road, Chaoyang District, Beijing, 100020, PR China.
Bioanalysis. 2019 Jun;11(13):1291-1302. doi: 10.4155/bio-2019-0114. Epub 2019 Aug 5.
Olanzapine (OLZ) is the first-line, cost-effectiveness treatment for schizophrenia in China. A quantitative ultrahigh performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for determination of OLZ in human plasma was developed. LC separation was achieved on Waters XBrige C column. ESI was involved and multiple reaction monitoring transitions were at 313.2→256.1 for OLZ and 316.2→256.1 IS (d3-OLZ). The linear range was 0.1-20 ng/ml with LLOQ of 0.1 ng/ml. Accuracy and precision were within 10%. The validated method was successfully applied to a bioequivalence study of OLZ disintegrating tablets at dose of 5 mg with 100% reproducibility evaluated by incurred sample reanalysis. A robust validated method was developed for quantitation of OLZ in human plasma.
奥氮平（OLZ）是中国治疗精神分裂症的一线、具有成本效益的药物。建立了一种定量超高效液相色谱-串联质谱（UPLC-MS/MS）法测定人血浆中的奥氮平。采用沃特世XBrige C柱进行液相色谱分离。采用电喷雾电离（ESI），奥氮平的多反应监测跃迁为313.2→256.1，内标（d3-奥氮平）为316.2→256.1。线性范围为0.1-20 ng/ml，定量下限为0.1 ng/ml。准确度和精密度在10%以内。该验证方法成功应用于5 mg剂量奥氮平分散片的生物等效性研究，通过测定再分析评估，重现性为100%。建立了一种可靠的验证方法用于定量测定人血浆中的奥氮平。
