Patel Bhavin N, Sharma Naveen, Sanyal Mallika, Shrivastav Pranav S
Chemistry Department, School of Sciences, Gujarat University, Navrangpura, Ahmedabad-380 009, India.
J Chromatogr Sci. 2010 Jan;48(1):35-44. doi: 10.1093/chromsci/48.1.35.
A rapid, sensitive, and accurate liquid chromatography-tandem mass spectrometry assay for simultaneous determination of loratadine (L) and its active metabolite, descarboethoxyloratadine (DCL), in human plasma is developed using desipramine as internal standard (IS). The analytes and IS are separated on a Betabasic cyano (100 mm x 2.1 mm, 5 microm) column and detected by tandem mass spectrometry with a turbo ion spray interface operating in positive ion and multiple reaction monitoring acquisition mode. The total chromatographic runtime is 3.0 min with retention time for L, DCL, and IS at 0.82, 1.58, and 1.97 min, respectively. The method is validated over a dynamic linear range of 0.05-15.00 ng/mL for both L and DCL with a correlation coefficient of r(2) 0.9984 and 0.9979, respectively. The intra-batch and inter-batch precision (%CV) across five levels (LLOQ, LQC, MQC, HQC, and ULOQ) is less than 9%. The method is successfully applied to a bioequivalence study of 10 mg loratadine tablet formulation in 28 healthy Indian male subjects under fasted condition.
建立了一种快速、灵敏且准确的液相色谱-串联质谱分析法，以地昔帕明为内标，同时测定人血浆中的氯雷他定（L）及其活性代谢物去乙氧羰基氯雷他定（DCL）。分析物和内标在贝塔碱性氰基柱（100 mm×2.1 mm，5μm）上分离，并通过串联质谱检测，采用涡轮离子喷雾接口，以正离子和多反应监测采集模式运行。总色谱运行时间为3.0分钟，L、DCL和内标的保留时间分别为0.82、1.58和1.97分钟。该方法在L和DCL的0.05-15.00 ng/mL动态线性范围内进行了验证，相关系数r(2)分别为0.9984和0.9979。五个水平（LLOQ、LQC、MQC、HQC和ULOQ）的批内和批间精密度（%CV）均小于9%。该方法成功应用于28名空腹健康印度男性受试者中10 mg氯雷他定片剂制剂的生物等效性研究。
