Optimization of separation and determination of moxifloxacin and its related substances by RP-HPLC

Journal of Pharmaceutical and Biomedical Analysis

Volumn 50, Issue 2, 2009, Pages 117-126

  Djurdjevic, Predrag ^a   Ciric, Andrija ^a   Djurdjevic, Aleksandra ^b   Stankov, Milena Jelikic ^c  

^a Faculty of Science   (Serbia)

^b Medicines and Medical Devices Agency of Serbia   (Serbia)

^c Faculty of Pharmacy   (Serbia)

Author keywords

Chemometry; Degradation; Impurities; Moxifloxacin; RP HPLC

Indexed keywords

MOXIFLOXACIN; OFLOXACIN; PHOSPHORIC ACID;

ARTICLE; CHEMOMETRIC ANALYSIS; CHROMATOGRAPHY; COMPUTER PROGRAM; COMPUTER SIMULATION; CONTROLLED STUDY; DEGRADATION KINETICS; DRUG IMPURITY; DRUG STRUCTURE; FLOW RATE; PH MEASUREMENT; PRIORITY JOURNAL; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SEPARATION TECHNIQUE; TEMPERATURE MEASUREMENT; VALIDATION STUDY;

ANTI-BACTERIAL AGENTS; AZA COMPOUNDS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HYDROGEN-ION CONCENTRATION; QUINOLINES; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SPECTROPHOTOMETRY, ULTRAVIOLET;

EID: 67349254127     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2009.03.029     Document Type: Article

References (26)

1. Kleemann A., Engel J., Kutscher B., and Reichert D. Pharmaceutical Substances, Synthesis, Patents, Applications. 4th Edition (2001), Thieme Medical Publ., Stuttgart pp. 1372-1374
2. Matrix Laboratories Ltd., India, PCT WO 2005/012285 A1; Cipla Ltd. India, WO 2008/059223.
3. Bayer AG, European Patent Office, EP 0350733 B1, EP 550903, EP 657448.
4. Bayer AG, Business Group Pharma, Data on file, Moxifloxacin HCl, November 2000.
5. Uwe Petersen. Quinolone antibiotics: the development of moxifloxacin. In: Fischer J., and Robin Ganellin C. (Eds). Analogue-based Drug Discovery (2006), Wiley-VCH Verlag, Weinheim
6. Boehlert J.P. Regulatory aspects: ICH and pharmacopoeial perspectives. In: Görög S. (Ed). Identification and Determination of Impurities in Drugs, Series: Progress in Pharmaceutical and Biomedical Analysis vol. 4 (2000), Elsevier
7. Görög S. The role of impurity profiling in drug research, development and production. In: Görög S. (Ed). Identification and Determination of Impurities in Drugs (2000), Elsevier, Amsterdam
8. In: Smith R.J., and Webb M.L. (Eds). Analysis of Drug Impurities (2007), Blackwell Publishing, Oxford
9. Laban-Djurdjević A., Stankov M.J., and Djurdjević P. J. Chromatogr. B 844 (2006) 104-111
10. Stass H., and Dalhoff A. J. Chromatogr. B 702 (1997) 163-174
11. Tatar Ulu S. J. Pharm. Biomed. Anal. 43 (2007) 320-324
12. Ravindra-Kumar Y., Prasad Raju V.V.N.K.V., Rajes Kumar R., Eswaraiah S., Mukkanti K., Suryanarayanna M.V., and Satyanarayana Reddy M. J. Pharm. Biomed. Anal. 34 (2004) 1125-1129
13. Motwani S.K., Khar R.K., Ahmad F.J., Chopra S., Kohli K., and Talegaonkar S. Anal. Chim. Acta 582 (2007) 75-82
14. Yacoub Salem M., El-Guindi N.M., Mikael H.K., and El-Sayed abd-el-Fattah L. Chem. Pharm. Bull. 54 (2006) 1625-1632
15. Wei L., Qin H.C., and Jun H.T. West China J. Pharm. Sci. 2 (2006) 270-272
16. Molnár I. J. Chromatogr. A 965 (2002) 175-194
17. ® Software. In: Kromidas S. (Ed). HPLC Made to Measure: A Practical Handbook for Optimization (2006), Wiley-VCH Verlag, Weinheim
18. DryLab Users Manual, LC Resources, Walnut Creek, CA, USA, 2000.
19. Horváth C., Melander W., and Molnár I. J. Chromatogr. A 125 (1976) 129-156
20. Montgomery D.C. Design and Analysis of Experiments. 5th Edition (2001), John Wiley & Sons, N.Y.
21. Burgess C. Valid Analytical Methods and Procedures (2000), The Royal Society of Chemistry, Cambridge pp. 27-39
22. Statistica v. 6, StatSoft, Tulsa, USA, 2001.
23. Langlois M.-H., Montagut M., Dubost J.-P., Grellet J., and Saux M.C. J. Pharm. Biomed. Anal. 37 (2005) 389-393
24. Vander Heyden Y., Hartmann C., Massart D.L., Michel L., Kiechle P., and Erni F. Anal. Chim. Acta 316 (1995) 15-26
25. Bliesner D.M. Validating Chromatographic Methods. A Practical Guide (2006), John Wiley & Sons, Hoboken, NJ
26. Ermer J., and McB J.H. Miller, Method Validation in Pharmaceutical Analysis A Guide to Best Practice (2005), Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim