Brown Stacy D, Connor Justin D, Smallwood Nicholas C, Lugo Ralph A
Department of Pharmaceutical Sciences, Bill Gatton College of Pharmacy East Tennessee State University, Box 70594, Johnson City, TN 37614, USA.
Int J Anal Chem. 2011;2011:832414. doi: 10.1155/2011/832414. Epub 2011 Jun 22.
An LC-MS/MS method was developed and validated to be used as a stability indicating assay for the study of a 3 mg/mL lansoprazole oral suspension. The method utilizes a UPLC (ultra-performance liquid chromatography) column and unique mass spectrometric detection (ion-trap time-of-flight (IT-TOF)) to achieve a sensitive (LOD 2 ng/mL), accurate, and reproducible quantification of lansoprazole. This method reports an intraday and interday coefficient of variation of 2.98 ± 2.17% (n = 5 for each concentration for each day) and 3.07 ± 0.89% (n = 20 for each concentration), respectively. Calibration curves (5-25 μg/mL) were found to be linear with an R(2) value ranging from 0.9972 to 0.9991 on 4 different days. Accuracy of the assay, expressed as % error, ranged from 0.30 to 5.22%. This method is useful for monitoring the stability of lansoprazole in oral suspension.
开发并验证了一种液相色谱-串联质谱（LC-MS/MS）方法，用作3mg/mL兰索拉唑口服混悬液稳定性研究的稳定性指示测定法。该方法采用超高效液相色谱（UPLC）柱和独特的质谱检测（离子阱飞行时间（IT-TOF）），以实现对兰索拉唑的灵敏（检测限2ng/mL）、准确且可重现的定量。该方法报告的日内和日间变异系数分别为2.98±2.17%（每天每种浓度n = 5）和3.07±0.89%（每种浓度n = 20）。在4个不同日期发现校准曲线（5-25μg/mL）呈线性，R(2)值范围为0.9972至0.9991。以%误差表示的测定准确度范围为0.30至5.22%。该方法可用于监测兰索拉唑口服混悬液的稳定性。
