Stability-indicating HPLC method for the determination of impurities in meprobamate with refractive index detection

Journal of Chromatographic Science

Volumn 48, Issue 3, 2010, Pages 212-218

  Karthikeyan, K ^a,b   Balaji, T S ^a   Shanmugasundaram, P ^a   Chandrasekara Pillai, K ^b  

^a Shasun Research Center   (India)

^b UNIVERSITY OF MADRAS   (India)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77949293752     PISSN: 00219665     EISSN: None     Source Type: Journal    
DOI: 10.1093/chromsci/48.3.212     Document Type: Article

References (24)

1. Merck & Co., Inc., The Merck index, 14th ed., Merk Research Laboratories, NJ, 2006, pp. 1013.
2. British Pharmacopoeia Commission, British Pharmacopoeia, London, 2008, pp. 1398-1399.
3. European Directorate for the Quality of Medicines & Healthcare (EDQM), European Pharmacopoeia 6.0, Council of Europe, France, pp. 2359.
4. US Pharmacopeial Convention, United States Pharmacopeia, USP31 NF26, The USP convention, Rockville, MD, 2008, pp. 2623-2624; 683-688
5. C. Shearer and P. Rulon. Analytical profiles of drug substances, Vol. 1, Academic press, NY, 1972, pp. 207-232
6. Alfred F. Zappala and Alex post. Rapid near IR spectrophotometric determination of meprobmate in pharmaceutical preparations. J. Pharm. Sci. 66: 292-293 (1977).
7. J.W. Turczan and T.C. Kram. Determination of meprobmate in tablets by NMR. J. Pharm. Sci. 56: 1643-1645 (1967).
8. M.P. Rabinowitz, P. Reisberg, and J.I. Bodin. GLC assay of meprobamate and related carbamates. J. Pharm. Sci. 61: 1974-1976 (1972).
9. T. Thierry, L. Denis, M. Herve, V. Richard, and C. Henri. Gas chromatographic determination of meprobamate in human plasma. J. Chromatogr. Biomed. Appl. 615: 343-346 (1993).
10. L. Mortis and R.H. Levy. GLC determination of meprobamate in water, plasma and urine. J. Pharm. Sci. 63: 834 (1974).
11. Y. Gaillard, J.P. Gay-Montchamp, and M. Ollagnier. Gas chromatographic determination of meprobamate in serum or plasma after solid-phase extraction. J. Chromatogr. Biomed. Appl. 577: 171-173 (1992).
12. L.F. Cullen, L.J. Heckman, and G.J. Papariello. Automated colorimetric method for the determination of meprobmate and other N-unsubstituted carbamate in pharmaceutical products. J. Pharm. Sci. 58: 1537-1539 (1969).
13. J.W. Poole, G.M. Irwin, and S. Young. Colorimetric assay procedure for dissolution studies of meprobamate formulations. J. Pharm. Sci. 60: 1850 (1971).
14. R.N. Gupta and F. Eng. GC and HPLC determination of meprobamate in plasma. J. High Res. Chromatogr. CC. 3: 419-420 (1980).
15. I. Bechet, A. Ceccato, PH. Hubert, P. Herne, and J. Crommen. Determination of meprobamate in pharmaceutical dosage forms also containing carbromal by liquid chromatography and indirect photometric detection. J. Pharm. Biomed. Anal. 10: 995-999 (1992).
16. P. Kintz and P. Mangin. Determination of meprobamate in human plasma, urine and hair by gas chromatography and electron impact mass spectrometry. J. Anal. Toxicol. 17: 408-410 (1993).
17. D. Sandrine, R. Damien, S. Bertrand, E. Alain, and C. Francois. A one-step and sensitive GC-MS assay for meprobamate determination in emergency situations. J. Anal. Toxicol. 30: 302-305 (2006).
18. I.L. Honigberg, J.T. Stewart, and M. Smith. Liquid chromatography in pharmaceutical analysis IX: Determination of muscle relaxant-analgesic mixtures using normal phase chromatography. J. Pharm. Sci. 67: 675 (1978).
19. R.C. Lawrence, E.G. Lovering, M.A. Poirier, and J.R. Watson. Impurities in Drugs V: Meprobamate. J. Pharm. Sci. 69: 1444-1445 (1980).
20. ICH Expert Working Group, Impurities in New Drug Substances, Harmonised Tripartite Guideline Q3A[R2], step 4, ICH, 2006.
21. U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Impurities in Drug substances, 2000
22. ICH Expert Working Group, Text on Validation of Analytical Procedures, Harmonised Tripartite Guideline Q2 (R1), step 4, ICH, 2005.
23. L.R. Snyder, J.L. Kirkland, and J.L. Glajch. Practical HPLC method development, 2nd ed., John Wiley & Sons, New York, NY, 1997, pp. 28-29; 50-57; 80-82.
24. I. Krull and M. Swartz. Determining specificity in a regulated environment. LC-GC 19: 604-614 (2001).