Controlled ex-vivo plasma hydrolysis of valaciclovir to acyclovir demonstration using tandem mass spectrometry

Biomedical Chromatography

Volumn 25, Issue 11, 2011, Pages 1189-1200

  Goswami, Dipanjan ^a   Khuroo, Arshad ^a   Gurule, Sanjay ^a   Modhave, Yogesh ^a   Monif, Tausif ^a  

^a RANBAXY LABORATORIES LTD   (India)

Author keywords

Drug: active metabolite formation ratio; LC MS MS; Plasma stability; Simultaneous method development validation; Valaciclovir controlled hydrolysis

Indexed keywords

BUFFER STORAGE; CONTROLLED DRUG DELIVERY; DRUG PRODUCTS; ION EXCHANGE; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; METABOLITES; PLASMA STABILITY; VIRUSES;

ACTIVE METABOLITES; CONTROLLED HYDROLYSIS; DRUG: ACTIVE METABOLITE FORMATION RATIO; EX-VIVO; LC-MS-MS; LC.MS/MS; METHOD DEVELOPMENT; SIMULTANEOUS METHOD DEVELOPMENT/VALIDATION; SIMULTANEOUS METHODS; VALACICLOVIR CONTROLED HYDROLYSIS;

HYDROLYSIS;

ACICLOVIR; EDETIC ACID; VALACICLOVIR; VALGANCICLOVIR; VALINE;

ACCURACY; ADULT; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG HYDROLYSIS; ELECTROSPRAY MASS SPECTROMETRY; EX VIVO STUDY; HUMAN; HUMAN EXPERIMENT; ION EXCHANGE CHROMATOGRAPHY; MALE; NORMAL HUMAN; PLASMA VOLUME; ROOM TEMPERATURE; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY; ANALOGS AND DERIVATIVES; BLOOD; CHEMISTRY; DRUG STABILITY; HYDROLYSIS; LIQUID CHROMATOGRAPHY; METABOLISM; PROCEDURES; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; STATISTICAL MODEL;

ACYCLOVIR; CHROMATOGRAPHY, LIQUID; DRUG STABILITY; HUMANS; HYDROLYSIS; LINEAR MODELS; MALE; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; TANDEM MASS SPECTROMETRY; VALINE;

EID: 80053612075     PISSN: 02693879     EISSN: 10990801     Source Type: Journal    
DOI: 10.1002/bmc.1590     Document Type: Article

References (14)

1. Brown SD, White CA and Bartlett MG. Hydrophilic interaction liquid chromatography/electrospray mass spectrometry determination of acyclovir in pregnant rat plasma and tissues. Rapid Communications in Mass Spectrometry 2002; 16: 1871-1876.
2. Goswami D, Gurule S, Khuroo AH and Monif T. Bioequivalence model for evaluation of Losartan in human plasma with special reference to drug-metabolite ratio. Clinical Research and Regulatory Affairs 2009; 26: 101-112.
3. Granero GE and Amidon GL. Stability of valacyclovir: implications for its oral bioavailability. International Journal of Pharmaceutics 2006; 317: 14-18.
4. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Bioanalytical Method Validation. Rockville, MD, 2001, Available from:.
5. Hughes NC, Bajaj N, Fan J and Wong EYK. Assessing the matrix effects of haemolysed samples in bioanalysis. Bioanalysis 2009; 1: 1057-1066.
6. Kanneti R, Rajesh R, Raj JRA and Bhatt PA. An LC-MS-MS method for the simultaneous quantification of acyclovir and valacyclovir in human plasma. Chromatographia 2009; 70: 407-414.
7. Kasiari M, Gikas E, Georgakakou S, Kazanis M and Panderi I. Selective and rapid liquid chromatography/negative-ion electrospray ionization mass spectrometry method for the quantification of valacyclovir and its metabolite in human plasma. Journal of Chromatography B: Biomedical Sciences and Applications 2008; 864: 78-86.
8. Kim I, Chu XY, Kim S, Provoda CJ, Lee KD and Amidon GL. Identification of a human valacyclovirase: biphenyl hydrolase-like protein as valacyclovir hydrolase. The Journal of Biological Chemistry 2003; 278: 25348-25356.
9. Ormrod D, Scott LJ and Perry CM. Valaciclovir A Review of its Long Term Utility in the Management of Genital Herpes Simplex Virus and Cytomegalovirus Infections. Drugs 2000; 59: 839-863.
10. Pham-Huy C, Sathoulopoulou F, Sandouk P, Scherrmann J-M, Palombo S and Girre C. Rapid determination of valaciclovir and acyclovir in human biological fluids by high-performance liquid chromatography using isocratic elution. Journal of Chromatography B: Biomedical Sciences and Applications 1999; 732: 47-53.
11. Soul-Lawton J, Seaber E, On N, Wootton R, Rolan P and Posner J. Absolute bioavailability and metabolic disposition of valaciclovir, the l-valyl ester of acyclovir, following oral administration to humans. Antimicrobial Agents and Chemotherapy 1995; 39: 2759-2764.
12. Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG and Weiner R. Workshop/Conference Report - quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. American Association of Pharmaceutical Scientists Journal 2007; 9: E30-E42.
13. Weller S, Blum MR, Doucette M, Burnette T, Cederberg DM, de Miranda P and Smiley ML. Pharmacokinetics of the acyclovir pro-drug valaciclovir after escalating single- and multiple-dose administration to normal volunteers. Clinical Pharmacology And Therapeutics 1993; 54: 595-605.
14. Yadav M, Upadhyaya V, Singhal P, Goswami S and Shrivastav PS. Stability evaluation and sensitive determination of antiviral drug, valacyclovir and its metabolite acyclovir in human plasma by a rapid liquid chromatography-tandem mass spectrometry method. Journal of Chromatography B: Biomedical Sciences and Applications 2009; 877: 680-688.