Liquid chromatography–electrospray ionisation mass spectrometry method for the determination of escitalopram in human plasma and its application in bioequivalence study

Abstract

A novel liquid chromatographic--electrospray ionisation mass spectrometric (LC--ESI-MS) method has been developed for the determination of escitalopram, an antidepressant in human plasma using paroxetine as internal standard. The method involved liquid--liquid extraction of the analyte from human plasma with a mixture of diethyl ether and dichloromethane (70:30, v/v). The chromatographic separation was achieved within 7.0 min by using 2.0 mM ammonium acetate (pH 5.0)--acetonitrile (54:46, v/v) as mobile phase and a ODS YMCAQ 150 mm x 4.6 mm analytical column; the flow-rate was 1.0 ml/min. Ion signals m/z 325.0 and 330.0 for escitalopram and internal standard, were measured in the positive mode. A detailed validation of the method was performed as per USFDA guidelines and the standard curves were found to be linear in the range of 1.0-200 ng/ml with a mean correlation coefficient more than 0.99. The absolute recovery was more than 75% for both escitalopram and internal standard. The method was simple, sensitive, precise, accurate and was successfully applied to the bioequivalence study of escitalopram in healthy, male, human subjects.

Enantioselective analysis of citalopram and demethylcitalopram in human and rat plasma by chiral LC‐MS/MS: Application to pharmacokinetics

“…20 In the present study, we report for the first time the enantioselective analysis of CITA and its metabolite DCITA in plasma of rats and healthy volunteers treated with a single dose of racemic CITA by LC-MS/MS using chiral phase column.…”

Bioequivalence Study of Two Formulations of Escitalopram Oxalate 20 mg Tablets in Healthy Volunteers

“…Conditions for Escitalopram extraction from plasma and chromatographic conditions for its quantification were determined after a previous revision of scientific literature, implementing necessary modifications to its optimization [22][23][24][25][26].…”

Spectrophotometric Determination of Escitalopram in Pharmaceuticals

“…Escitalopram blocks the reuptake of serotonin at the serotonin reuptake pump of the neuronal membrane, enhancing the actions of serotonin on 5HT1A auto receptors 3 . Literature survey reveals several spectroscopic 4,5,6 , HPLC 7 and HPTLC of Escitalopram hydrobromide were transferred into a series of 10 mL standard flasks using a micro burette. To this, 1 mL of 5 mol L -1 HCl and bromate-bromide mixture (30 µg mL -1 in KBrO 3 ) were added.…”