A validated chira; HPLC method for the determination of mebeverine HCI enantiomers in pharmaceutical dosage forms and spiked rat plasma

Biomedical Chromatography

Volumn 20, Issue 2, 2006, Pages 211-216

  Radwan, Mahasen A ^a   Abdine, Heba H ^a   Aboul Enein, Hassan Y ^b  

^a KING SAUD UNIVERSITY   (Saudi Arabia)

^b KING FAISAL SPECIALIST HOSPITAL AND RESEARCH CENTER   (Saudi Arabia)

Author keywords

Cellulose tris (3,5 dimethylphenyl carbamate) chiral stationary phase; Chiral HPLC assay; Dosage forms; Enantiomers; Mebeverine; Plasma

Indexed keywords

DRUG PRODUCTS; ENANTIOMERS; HEXANE;

CELLULOSE TRIS (3,5-DIMETHYLPHENYL CARBAMATE) CHIRAL STATIONARY PHASE; CHIRAL HPLC; CHIRAL HPLC ASSAY; CHIRAL STATIONARY PHASE; DOSAGE FORMS; HPLC METHOD; MEBEVERINE; PHARMACEUTICAL DOSAGE FORMS; RAT PLASMA; SIMPLE++;

CELLULOSE;

2 PROPANOL; HEXANE; MEBEVERINE; TRIETHYLAMINE; PHENETHYLAMINE DERIVATIVE;

ACCURACY; ANIMAL EXPERIMENT; ARTICLE; BLOOD SAMPLING; CHIRAL CHROMATOGRAPHY; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG DOSAGE FORM; DRUG DOSE REGIMEN; DRUG SPECIFICITY; DRUG STABILITY; DRUG STRUCTURE; ENANTIOMER; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; NONHUMAN; RAT; REGRESSION ANALYSIS; REPRODUCIBILITY; SEPARATION TECHNIQUE; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; VALIDATION PROCESS; ANIMAL; BLOOD; METHODOLOGY; SENSITIVITY AND SPECIFICITY; STEREOISOMERISM; VALIDATION STUDY;

ANIMALIA; CHIRA;

ANIMALS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; PHENETHYLAMINES; RATS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; STEREOISOMERISM;

EID: 32544457693     PISSN: 02693879     EISSN: 10990801     Source Type: Journal    
DOI: 10.1002/bmc.556     Document Type: Article

References (17)

1. Aboul-Enein HY and Wainer IW. The Impact of Stereochemistry on Drug Development and Use. Wiley: New York, 1997.
2. De Schutter JA, Van der Weken G, Van den Bossche W and De Moerloose P. Reversed-phase high-performance thin-layer chromatography of mebeverine hydrochlordie and related compounds. Journal of Chromatography A 1985; 350: 135.
3. El-Walily AFM, El-Gindy A and Bedair MF. Application of first-derivative UV-spectrophotometry, TLC-densitometry and liquid chromatography for the simultaneous determination of mebeverine hydrochloride and sulpiride. Journal of Pharmaceutical and Biomedical Analysis 1999; 21: 535.
4. Evans PR, Bak YT and Kellow JE. Mebeverine alters small bowel motility in irritable bowel syndrome. Aliment Pharmacology and Therapeutics 1996; 10: 787.
5. Hoogewijs G and Massart DL. Development of a standardized analysis strategy for basic drugs using ion-pair extraction and high-performance liquid chromatography. VIII. Method construction for the determination of mebeverine in tablets and biological fluids. Journal of Chromatography B: Biomedical. Science and Applications 1986; 377: 391.
6. Ibrahim H, Issa YM and Abu-Shawish HM. Potentiometric flow injection analysis of mebeverine hydrochloride in serum and urine. Journal of Pharmaceutical and Biomedical Analysis 2005; 36: 1053.
7. Kraemer T, Bickeboeller-Friedrich J and Maurer HH. On the metabolism of the amphetamine-derived antispasmodic drug mebeverine: gas chromatography-mass spectrometry studies on rat liver microsomes and on human urine. Drug Metabolism and Disposition 2000; 28: 339.
8. Kristinsson J, Snorradottir I and Johannsson M. The metabolism of mebeverine in man: Identification of urinary metabolites by gas chromatography/mass spectrometry. Pharmacology and Toxicology 1994; 74: 174.
9. Pinkston JD, Venkatramani CJ, Tulich LJ, Bowling DJ and Wehmeyer KR. Evaluation of capillary supercritical fluid chromatography with mass spectrometric detection for the analysis of a drug (mebeverine) in a dog plasma matrix. Journal of Chromatography A 1993; 622: 209.
10. Radwan MA, Foda NH and Al Deeb OA. Analytical Profile of Drug Substances and Excipients, Vol. 25, Brittain HG (ed). Academic Press: New York, 1998; 165.
11. Ritchie JA and Truelove SC. Comparison of various treatments for irritable bowel syndrome. British Medical Journal 1980; 281: 1317.
12. Shama SA and Amin AS. Spectrophotometric microdetermination of efopam, mebeverine and phenylpropanolamine hydrochloride in pharmaceutical formulations using alizarins. Spectrochimica Acta Part A 2004; 160: 769.
13. Somsen GW, Mol R and de Jong GJ. On-line micellar electrokinetic chromatography-mass spectrometry: feasibility of direct introduction of non-volatile buffer and surfactant into the electrospray interface. Journal of Chromatography A 2003; 1000: 953.
14. Stockis A, Guelen PJ and Vos Dde. Identification of mebeverine acid as the main circulating metabolite of mebeverine in man. Journal of Pharmaceutical and Biomedical Analysis 2002; 29: 335.
15. Sweetman SC (ed.). Martindale, The Complete Drug Reference, 33rd edn. Pharmaceutical Press: Massachusetts, 1999; 1233.
16. The Britsh Pharmacopoeia. HMSO: London, 2000; 2076.
17. Tulich LJ Randall JL, Kelm GR and Wehmeyer KR. Determination of two mebeverine metabolites, mebeverine alcohol and desmethylmebeverine alcohol, in human plasma by a dual stable isotope-based gas chromatographic-mass spectrometric method. Journal of Chromatography B: Biomedical Applications 1996; 682: 273.