Published:Journal of Chromatographic Science, ISSN 0021-9665 Volume 48, Number 1, January 2010, pp. 35-44

LC–MS-ESI for the Determination of Loratadine and Descarboethoxyloratadine in Human Plasma

Bhavin N. Patel^1,2, Naveen Sharma², Mallika Sanyal³, and Pranav S. Shrivastav¹,
¹Chemistry Department, School of Sciences, Gujarat University, Navrangpura, Ahmedabad-380 009, India;
²Analytical Laboratory, BA Research India Ltd., Bodakdev, Ahmedabad-380 054, India;
³Chemistry Department, St. Xaviers’ College, Navrangpura, Ahmedabad-380 009, India

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 × 2.1 mm, 5 µm) 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 r² 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.

Reproduction of editorial content of this journal is prohibited without publisher’s permission.

Site Map: Home | Current Issue | Subscribe | Back Issues | About Us | Meetings | Advertising |
| Books for Sale | For the Author | Links | Supplier Info | Search |