Development and Validation of an LC-MS/MS-ESI Method for Comparative Pharmacokinetic Study of Ciprofloxacin in Healthy Male Subjects

Drug Research

Volumn 67, Issue 2, 2017, Pages 94-102

  Choudhury, Hira ^a,b   Gorain, Bapi ^a,c   Paul, Anwesha ^a   Sarkar, Pradipta ^a   Dan, Shubhasis ^a   Chakraborty, Pragnya ^a   Pal, Tapan K ^a  

^a JADAVPUR UNIVERSITY   (India)

^b INTERNATIONAL MEDICAL UNIVERSITY   (Malaysia)

^c LINCOLN UNIVERSITY COLLEGE   (Malaysia)

Author keywords

bioequivalence study; ciprofloxacin; human plasma; LC MS MS; method validation

Indexed keywords

CHLOROFORM; CIPROFLOXACIN; FORMIC ACID; METHANOL; OFLOXACIN; WATER;

ACCURACY; ADULT; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; DRUG BLOOD LEVEL; ELECTROSPRAY MASS SPECTROMETRY; ELIMINATION HALF-LIFE; FLOW RATE; FREEZE THAWING; HUMAN; LIQUID CHROMATOGRAPHY; LIQUID LIQUID EXTRACTION; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PLASMA CONCENTRATION-TIME CURVE; SENSITIVITY AND SPECIFICITY; TANDEM MASS SPECTROMETRY; VALIDATION STUDY; BLOOD; CALIBRATION; CROSSOVER PROCEDURE; DRUG STABILITY; PROCEDURES; RANDOMIZED CONTROLLED TRIAL; STANDARDS; THERAPEUTIC EQUIVALENCE;

CALIBRATION; CHROMATOGRAPHY, LIQUID; CIPROFLOXACIN; CROSS-OVER STUDIES; DRUG STABILITY; HUMANS; LIQUID-LIQUID EXTRACTION; MALE; SENSITIVITY AND SPECIFICITY; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; TANDEM MASS SPECTROMETRY; THERAPEUTIC EQUIVALENCY;

EID: 84994632797     PISSN: 21949379     EISSN: 21949387     Source Type: Journal    
DOI: 10.1055/s-0042-116593     Document Type: Article

References (37)

1. Douros A., Grabowski K., Stahlmann R. Safety issues and drug-drug interactions with commonly used quinolones. Expert Opin Drug Metab Toxicol: 2015; 11 25 39
2. Redgrave L. S., Sutton S. B., Webber M. A. et al. Fluoroquinolone resistance: mechanisms, impact on bacteria, and role in evolutionary success. Trends Moicrobiol: 2014; 22 438 445
3. Chin N. X., Neu H. C. Ciprofloxacin, a quinolone carboxylic acid compound active against aerobic and anaerobic bacteria. Antimicrob Agents Chemother: 1984; 25 319 326
4. Eliopoulos G. M., Gardella A., Moellering R. C. In vitro activity of ciprofloxacin, a new carboxyquinoline antimicrobial agent. Antimicrob Agents Chemother: 1984; 25 331 335
5. Deborah C-R, John P. M., Allan P. et al. Ciprofloxacin. A review of its antimicrobial activity, pharmacokinetic properties and therapeutic use. Drugs: 1988; 35 373 447
6. Kamberi M., Tsutsumi K., Kotegawa T. et al. Determination of ciprofloxacin in plasma and urine by HPLC with ultraviolet detection. Clin Chem: 1998; 44 1251 1255
7. Cazedey EC L., Salgado HR N. Spectrophotometric determination of ciprofloxacin hydrochloride in ophthalmic solution. Advances in Analytical Chemistry: 2012; 2 74 79
8. Mostafa S., El-Sadek M., Alla E. A. Spectrophotometric determination of ciprofloxacin, enrofloxacin and pefloxacin through charge transfer complex formation. J Pharm Biomed Anal: 2002; 27 133 142
9. Scheer F., Krämer I. A liquid chromatography assay for the simultaneous quantification of piperacillin and ciprofloxacin in human plasma and dialysate in critically ill patients undergoing continuous renal replacement therapy. Int J Anal Mass Spectrom Cromatogr: 2014; 2 43 51
10. Ibrahim M. A., Aboul-enein H. Y., Niazy E. M. et al. High performance liquid chromatographic assay of ciprofloxacin in human plasma using fluorescence detection. GU J Sci: 2013; 26 31 37
11. Hussain A., Hanif M., Shoiab M. H. et al. Bioanalytical method development and validation of ciprofloxacin by RP-HPLC method. Asian J Phar Biol Res: 2012; 2 219 224
12. Muchohi S. N., Thuo N., Karisa J. et al. Determination of ciprofloxacin in human plasma using high-performance liquid chromatography coupled with fluorescence detection: Application to a population pharmacokinetics study in children with severe malnutrition. J Chromatogr B Analyt Technol Biomed Life Sci: 2011; 879 146 152
13. De Smet J., Boussery K., Colpaert K. et al. Pharmacokinetics of fluoroquinolones in critical care patients: A bio-analytical HPLC method for the simultaneous quantification of ofloxacin, ciprofloxacin and moxifloxacin in human plasma. J Chromatogr B: Anal Technol Biomed Life Sci: 2009; 877 961 967
14. Pellegrino R. M., Segoloni F., Cagini C. Simultaneous determination of Ciprofloxacin and the active metabolite of Prulifloxacin in aqueous human humor by high-performance liquid chromatography. J Pharm Biomed Anal: 2008; 47 567 574
15. Khan M. K., Khan M. F. Assessment of bioequivalence of ciprofloxacin in healthy male subjects using HPLC. Pak J Pharm Sci: 2008; 21 299 306
16. Wu S. S., Chein C. Y., Wen Y. H. Analysis of ciprofloxacin by a simple high-performance liquid chromatography method. J Chromatogr Sci: 2008; 46 490 495
17. Imre S., Dogaru M. T., Vari C. E. et al. Validation of an HPLC method for the determination of ciprofloxacin in human plasma. J Pharm Biomed Anal: 2003; 33 125 130
18. Maya M. T., Goncalves N. J., Silva N. B. et al. Simple high-performance liquid chromatographic assay for the determination of ciprofloxacin in human plasma with ultraviolet detection. J Chromatogr B: Biomed Sci Appl: 2001; 755 305 309
19. Krol G. J., Beck G. W., Benham T. HPLC analysis of ciprofloxacin and ciprofloxacin metabolites in body fluids. J Pharm Biomed Anal: 1995; 14 181 190
20. Zhai S., Korrapati M. R., Wei X. et al. Simultaneous determination of theophylline, enoxacin and ciprofloxacin in human plasma and saliva by high-performance liquid chromatography. J Chromatogr B: Biomed Appl: 1995; 669 372 376
21. Mack G. HPLC analysis of ciprofloxacin and ciprofloxacin metabolites in body fluids. J Chromatogr: 1992; 582 263 267
22. Pou-Clave L., Campos-Barreda F., Pascual-Mostaza C. Determination of ciprofloxacin in human serum by liquid chromatography. J Chromatogr: 1991; 563 211 215
23. Faria A. F., de Souza MV N., de Oliveira MA L. Validation of a capillary zone electrophoresis method for the determination of ciprofloxacin, gatifloxacin, moxifloxacin and ofloxacin in pharmaceutical formulations. J Braz Chem Soc: 2008; 19 389 396
24. Grondin C., Zhao W., Fakhoury M. et al. Determination of ciprofloxacin in plasma by micro-liquid chromatography-mass spectrometry: an adapted method for neonates. Biomed Chromatogr: 2011; 25 827 832
25. Zotou A., Miltiadou N. Sensitive LC determination of ciprofloxacin in pharmaceutical preparations and biological fluids with fluorescence detection. J Pharm Biomed Anal: 2002; 28 559 568
26. Kim S-Y, Song I-D, Kim H-J et al. Quantification of ciprofloxacin in human plasma by validated LC-MS/MS using ofloxacin as an internal standard and its clinical application. Curr Pharmaceut Anal: 2015; 11 239 247
27. Harrington M. M., Dolan J. W. When ideal isn't practical. LC GC N AM: 2001; 19 956 960
28. Pitt J. J. Principles and applications of liquid chromatography-mass spectrometry in clinical biochemistry. Clin Biochem Rev: 2009; 30 19 34
29. Sengupta P., Sarkar A. K., Bhaumik U. et al. Development and validation of an LC-ESI-MS/MS method for simultaneous quantitation of olmesartan and pioglitazone in rat plasma and its pharmacokinetic application. Biomed Chromatogr: 2010; 24 1342 1349
30. Choudhury H., Gorain B., Das A. et al. Development and validation of a sensitive HPLC-MS/MS-ESI method for determination of febuxostat: Application to pharmacokinetic study. Curr Anal Chem: 2014; 10 528 536
31. Food and Drug Administration of the United States, May 2001. Guidance for Industry Bioanalytical Method Validation. http://www.fda.gov/cder/guidance/index.html (accessed: 12.11.11)
32. Bansal S., DeStefano A. Key elements of bioanalytical method validation for small molecule. AAPS J: 2007; 9 Article 11.E109 E114.S
33. Roy B., Choudhury H., Das A. et al. Development and validation of a liquid chromatography - tandem mass spectrometry method to determine ulifloxacin, the active metabolite of prulifloxacin in rat and rabbit plasma: application to toxicokinetic study. Biomed Chromatogr: 2011; 25 890 901
34. Gorain B., Choudhury H., Nandi U. et al. Development and validation of an HPLC method for simultaneous detection and quantification of paracetamol and etodolac in human plasma and its application to a pharmacokinetic study. J AOAC Int: 2013; 96 573 579
35. th WMA General Assembly, Brazil, October 2013. Available from: http://www.wma.net/en/30publications/10policies/b3/
36. Gorain B., Choudhury H., Halder D. et al. A comparative pharmacokinetic study of a fixed dose combination for essential hypertensive patients: A randomized crossover study in healthy human volunteers. Drug Res (Stuttg): 2013; 63 177 184
37. Nandi U., Gorain B., Choudhury H. et al. Development and validation of a high-performance liquid chromatographic method with ultraviolet detection for quantitation of lornoxicam in human plasma: Application to bioequivalence study. J Pharm Res: 2011; 4 3203 3205