BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF PREGABALIN IN RAT PLASMA BY SOLID PHASE EXTRACTION WITH HPLC-MS/MS: APPLICATION TO A PHARMACOKINETIC STUDY

被引:6
作者
Karavadi, Thejo Moorthy [1 ]
Challa, B. R. [2 ]
机构
[1] Pacific Univ Higher Educ & Res, Udaipur, Rajestan, India
[2] Nirmala Coll Pharm, Dept Pharmaceut Chem, Kadapa 516002, Andhra Pradesh, India
关键词
anticonvulsant; HPLC-MS; MS; pharmacokinetic study; pregabalin; rat plasma; solid-phase extraction; LC-MS-MS; FLUORESCENCE DETECTION; O-PHTALDIALDEHYDE; DERIVATIZATION; SEPARATION;
D O I
10.1080/10826076.2012.738617
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
The most suitable bioanalytical method based on solid phase extraction has been developed and validated for quantification of pregabalin in rat plasma. Pregabalin D4 was used as an internal standard for pregabalin. Thermo Hypurity C18 (4.6mmx150mm, 5.0 mu m) column provided chromatographic separation of analyte followed by detection with mass spectrometry. The method involved simple isocratic chromatographic separation and mass spectrometric detection in the positive ionization mode using an API-4000 system. The total run time was 3.5 minutes. The proposed method has been validated with the linear range of 0.50-20000.00ng/mL for Pregabalin. The intra-run and inter-run precision values were within 1.05 to 4.81% and 1.57 to 3.90%, respectively. The overall recovery for pregabalin and pregabalin D4 was 86.49% and 86.57%, respectively. This validated method was successfully applied into the pharmacokinetic study of rat plasma.
引用
收藏
页码:130 / 144
页数:15
相关论文
共 23 条
[1]  
[Anonymous], 2001, Guidance for industry, bioanalytical method validation
[2]  
[Anonymous], 2003, GUID IND BIOAV FED B
[3]   Analysis of pregabalin at therapeutic concentrations in human plasma/serum by reversed-phase HPLC [J].
Berry, D ;
Millington, C .
THERAPEUTIC DRUG MONITORING, 2005, 27 (04) :451-456
[4]   Can a Single Dose of 300 mg of Pregabalin Reach Acute Antihyperalgesic Levels in the Central Nervous System? [J].
Buvanendran, Asokumar ;
Kroin, Jeffrey S. ;
Kari, Maruti ;
Tuman, Kenneth J. .
REGIONAL ANESTHESIA AND PAIN MEDICINE, 2010, 35 (06) :535-538
[5]   Determination of optical impurity of pregabalin by HPLC with pre-column chiral derivatization [J].
Chen, Xiaohui ;
Zhang, Daolin ;
Deng, Jie ;
Fu, Xiaotai .
JOURNAL OF CHROMATOGRAPHIC SCIENCE, 2008, 46 (01) :42-44
[6]   Liquid chromatographic separation of pregabalin and its possible impurities with fluorescence detection after postcolumn derivatization with o-phtaldialdehyde [J].
Dousa, Michal ;
Gibala, Petr ;
Lemr, K. .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2010, 53 (03) :717-722
[7]   A High-Performance Liquid Chromatography Assay to Monitor the New Antiepileptic Drug Lacosamide in Patients With Epilepsy [J].
Greenaway, Clare ;
Ratnaraj, Neville ;
Sander, Josemir W. ;
Patsalos, Philip N. .
THERAPEUTIC DRUG MONITORING, 2010, 32 (04) :448-452
[8]  
Guidance for Industry, 2002, GUID IND FOOD EFF BI
[9]   Highly selective asymmetric hydrogenation using a three hindered quadrant bisphosphine rhodium catalyst [J].
Hoge, G ;
Wu, HP ;
Kissel, WS ;
Pflum, DA ;
Greene, DJ ;
Bao, J .
JOURNAL OF THE AMERICAN CHEMICAL SOCIETY, 2004, 126 (19) :5966-5967
[10]   Development and Validation of HPLC Method for the Determination of Pregabalin in Capsules [J].
Kasawar, G. B. ;
Farooqui, M. N. .
INDIAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2010, 72 (04) :517-519