Development and validation of an RP-HPLC method for the simultaneous determination of Escitalopram Oxalate and Clonazepam in bulk and its pharmaceutical formulations

Abstract

A Simple, efficient and reproducible reverse phase high performance liquid chromatographic method was developed and validated for the Simultaneous determination of Escitalopram oxalate and Clonazepam in combined dosage form. The separation was effected on a Hypersil ODS C18 column (250mm X 4.6mm; 5µ) using a mobile phase mixture of buffer and acetonitrile in a ratio of 50:50 v/v at a flow rate of 1.0ml/min. The detection was made at 240nm. The retention time of Escitalopram oxalate and Clonazepam was found to be 2.840± 0.007min and 4.007±0.006 min. Calibration curve was linear over the concentration range of 20-120µg/ml and 1-6µg/ml for Escitalopram oxalate and Clonazepam. All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. The developed method is also found to be precise, accurate, specific, robust and rapid for the simultaneous determination of Escitalopram oxalate and Clonazepam in tablet dosage forms.DOI: http://dx.doi.org/10.3329/icpj.v1i8.11249 International Current Pharmaceutical Journal 2012, 1(8): 193-198

Selective LC–MS/MS determination of citalopram enantiomers and application to a pharmacokinetic evaluation of generic and reference formulations

“…As observed, stationary phases consisted of silica chemically bound to n-alkyl groups (C18, CN, Select B) (Bhimanadhuni et al, 2012;De Sousa et al, 2012;El-Gindy et al, 2006;Malfará et al, 2007;Peng et al, 2016;Ragab & Bahgat, 2019;Skibi nski & Misztal, 2007), chiral selectors (β-cyclodextrin or cellulose derivatives) (Geryk et al, 2013;Haupt, 1996;Hegstad et al, 2017;Kosel et al, 1998;Rahman et al, 2017;Rocha et al, 2007;et al, 1995a, 1995bWeisskopf et al, 2016), and sol-gel capillary monolith (Johannesson & Bergquist, 2007). The HPLC coupled to FL (Kosel et al, 1998;Rochat et al, 1995aRochat et al, , 1995b, UV (Bhimanadhuni et al, 2012;El-Gindy et al, 2006;Geryk et al, 2013;Haupt, 1996;Malfará et al, 2007;Peng et al, 2016;Ragab & Bahgat, 2019;Rahman et al, 2017;Skibi nski & Misztal, 2007;Zheng et al, 2000), or MS/MS detectors (De Sousa et al, 2012;Golovko et al, 2016;Hegstad et al, 2017;Rocha et al, 2007;Weisskopf et al, 2016) was applied to quantify the (R/S)-CTP and/or the enantiomers in plasma, milk, soil, tissues, raw material, and formulations. Additional analytical techniques such as ultra-high performance supercritical fluid chromatography-MS/MS (Hegstad et al, 2017) and capillary electrophoresis instrument coupled to time-of-fligh...…”

“…The HPLC methods with UV or FL detection described until now (Table 5) were applied to assess the quality of the raw materials and drug formulations (Bhimanadhuni et al, 2012;El-Gindy et al, 2006;Geryk et al, 2013;Peng et al, 2016;Ragab & Bahgat, 2019;Rahman et al, 2017), as well as the drug plasma concentrations (Haupt, 1996;Kosel et al, 1998;Malfará et al, 2007;Ragab & Bahgat, 2019;Rochat et al, 1995aRochat et al, , 1995bZheng et al, 2000). However, their longer running time, lower sensitivity, and selectivity compared to the LC-MS/MS methods may limit their applications in pharmacokinetic studies, specially due the long halflife of (R/S)-CTP (Pollock, 2001) and (S)-CTP (Pastoor & Gobburu, 2014).…”

Development and Evaluation of Novel Estimation Techniques for in Vitro Dissolution Study and Validation Protocol for Escitalopram as Antidepressant Drug and Their Formulation

“…The various RP-HPLC methods have been studied for the analysis of escitalopram in bulk and various dosage forms [3][4][5][6][7][8][9][10][11][12][13]. However, the reported methods are less specific and also time-consuming.…”

“…Literature survey reveals spectrophotometric, RP-HPLC [3][4][5][6][7][8][9][10][11][12][13], and HPTLC [14] methods for these compounds either individually or in combination with other dosage forms. The literature review does not show any stability indicating RP-HPLC method for quantification of escitalopram.…”

Development of Spectrophotometric Method for Estimating Clonazepam in its Pure Form and in Pharmaceutical Tablets

“…formulations including spectrophotometry 6,7,8,9, GC-MS chromatography 10, HPLC 11,12 capillary electrophoresis 13, electrochem-iluminescence sensors 14 , Voltammetry 15 , potentiometry 16,17 . The purpose of this work is to develop a simple, rapid and accurate spectrophotometric method to measure the quantities (CLZ.)…”