Highly efficient, selective, sensitive and stability indicating RP-HPLC-UV method for the quantitative determination of potential impurities and characterization of four novel impurities in eslicarbazepine acetate active pharmaceutical ingredient by LC/ESI-IT/MS/MS

Journal of Pharmaceutical and Biomedical Analysis

Volumn 61, Issue , 2012, Pages 165-175

  Thomas, Saji ^a   Bharti, Amber ^a   Maddhesia, Pawan Kumar ^a   Shandilya, Sanjeev ^a   Agarwal, Ashutosh ^a   Dharamvir, ^a   Biswas, Sujay ^a   Bhansal, Vikas ^a   Gupta, Ashish Kumar ^a   Tewari, Praveen Kumar ^a   Mathela, Chandra S ^b  

^a Jubilant Life Sciences Ltd   (India)

^b KUMAUN UNIVERSITY   (India)

Author keywords

Characterization; Eslicarbazepine acetate; Impurity; LC MS MS; Validation

Indexed keywords

10 ACETOXY 5H DIBENZ[B,F]AZEPINE 5 CARBOXAMIDE; 10 METHOXY 5H DIBENZ[B,F]AZEPINE; 10 METHOXY DIBENZ[B,F]AZEPIN 5 YL ACETATE; 10 METHOXY DIBENZ[B,F]AZEPINE 5 CARBOXAMIDE; 10 OXO 10,11 DIHYDRO 5H DIBENZ[B,F]AZEPINE 5 CARBOXAMIDE; 10,11 DIHYDRO 5H DIBENZ[B,F]AZEPIN 10 OL; 10,11 DIHYDRO DIBENZ[B,F]AZEPINE 5 CARBOXAMIDE; 5 ACETYL 10,11 DIHYDRO 5H DIBENZ[B,F]AZEPIN 10 YL ACETATE; 5 ACETYL 5,11 DIHYDRO 10H DIBENZ[B,F]AZEPIN 10 ONE; 5 ACETYL 5H DIBENZ[B,F]AZEPIN 10 YL ACETATE; 5,11 DIHYDRO 10H DIBENZ[B,F]AZEPIN 10 ONE; 9 ACRIDINECARBOXYLIC ACID; DIBENZ[B,F]AZEPINE 5 CARBOXAMIDE; ESLICARBAZEPINE; ESLICARBAZEPINE ACETATE; N ACETYL 5H DIBENZ[B,F]AZEPINE 5 CARBOXAMIDE; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; DRUG DETERMINATION; DRUG IMPURITY; DRUG SELECTIVITY; DRUG STABILITY; DRUG STRUCTURE; ELECTROSPRAY; INFRARED SPECTROSCOPY; ION TRAP MASS SPECTROMETRY; LINEAR SYSTEM; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; NUCLEAR MAGNETIC RESONANCE; PRIORITY JOURNAL; PRODUCTIVITY; QUANTITATIVE ASSAY; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SENSITIVITY ANALYSIS; ULTRAVIOLET SPECTROSCOPY;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, LIQUID; DIBENZAZEPINES; DRUG CONTAMINATION; DRUG STABILITY; MAGNETIC RESONANCE SPECTROSCOPY; MASS SPECTROMETRY; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; SPECTROPHOTOMETRY, ULTRAVIOLET; SPECTROSCOPY, FOURIER TRANSFORM INFRARED; TANDEM MASS SPECTROMETRY;

EID: 84856110540     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.11.024     Document Type: Article

References (8)

1. Alves G., Figueiredo I., Castel-Branco M., Loureiro A., Fortuna A., Falcao A., Caramona M. Enantioselective HPLC-UV method for determination of eslicarbazepine acetate (BIA 2-093) and its metabolites in human plasma. Biomed. Chromatogr. 2007, 21:1127-1134.
2. Alves G., Fortuna A., Sousa J., Direito R., Almeida A., Rocha M., Falcao A., Soares-da-Silva P. Enantioselective assay for therapeutic drug monitoring of eslicarbazepine acetate: no interference with carbamazepine and its metabolites. Ther. Drug Monit. 2010, 32:512-516.
3. Fortuna A., Sousa J., Alves G., Falcao A., Soares-da-Silva P. Development and validation of an HPLC-UV method for the simultaneous quantification of carbamazepine, oxcarbazepine, eslicarbazepine acetate and their main metabolites in human plasma. Anal. Bioanal. Chem. 2010, 397:1605-1615.
4. Almeida L., Soares-da-Silva P. Eslicarbazepine acetate (BIA 2-093). Neurotherapeutics 2007, 4:88-96.
5. Mone M.K., Chandrasekhar K.B. Development of liquid chromatographic enantiomer separation methods and validation for the estimation of (R)-enantiomer in eslicarbazepine acetate. J. Pharm. Biomed. Anal. 2011, 54:248-251.
6. K.J. Prabahar, P.B. Kulkarni, S.B. Sawant, N.D. Limbekar, Glenmark generics limited, United States patent 0173893 A1 (2010).
7. ICH Guidelines, Q3A (R2), Impurities in new drug substances, October 25, 2006.
8. ICH Guidelines, Q2 (R1), Validation of analytical procedures: test and methodology, November, 2005.