Raman spectroscopic method for the determination of medroxyprogesterone acetate in a pharmaceutical suspension: validation of quantifying abilities, uncertainty assessment and comparison with the high performance liquid chromatography reference method

Analytica Chimica Acta

Volumn 589, Issue 2, 2007, Pages 192-199

  De Beer, T R M ^a   Baeyens, W R G ^a   Vermeire, A ^b   Broes, D ^b   Remon, J P ^a   Vervaet, C ^a  

^a GHENT UNIVERSITY   (Belgium)

^b PFIZER INC   (United States)

Author keywords

Accuracy profile; Alternative measurement method; Comparison; Medroxyprogesterone acetate; Pharmaceutical suspension; Polynomial curve; Raman spectroscopy; Uncertainty measurement

Indexed keywords

DRUG PRODUCTS; LIQUID CHROMATOGRAPHY; MATHEMATICAL MODELS; RAMAN SPECTROSCOPY; SUSPENSIONS (FLUIDS); UNCERTAINTY ANALYSIS;

ACCURACY PROFILES; ALTERNATIVE MEASUREMENT METHODS; MEDROXYPROGESTERONE ACETATES (MPA); PHARMACEUTICAL SUSPENSIONS; POLYNOMIAL CURVES; UNCERTAINTY MEASUREMENTS;

ENZYMES;

MEDROXYPROGESTERONE ACETATE;

ACCURACY; ARTICLE; CALIBRATION; DRUG DETERMINATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INTERMETHOD COMPARISON; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RAMAN SPECTROMETRY; SUSPENSION; VALIDATION PROCESS;

CALIBRATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; MEDROXYPROGESTERONE 17-ACETATE; PHARMACEUTICAL PREPARATIONS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SPECTRUM ANALYSIS, RAMAN;

EID: 34047149873     PISSN: 00032670     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.aca.2007.03.002     Document Type: Article

References (47)

1. Vankeirsbilck T., Vercauteren A., Baeyens W., Van der Weken G., Verpoort F., Vergote G., and Remon J.P. TrAC 21 (2002) 869
2. Vergote G.J., Vervaet C., Remon J.P., Haemers T., and Verpoort F. Eur. J. Pharm. Sci. 16 (2002) 63
3. McCreery R.L. Raman Spectroscopy for Chemical Analysis (2000), Wiley-Interscience, New York, USA
4. Long D.A. The Raman Effect: A Unified Treatment of the Theory of Raman Scattering by Molecules (2002), Wiley-Interscience, Chichester, West Sussex, England 597pp
5. Compton D.A.C., and Compton S.V. Appl. Spectrosc. 45 (1991) 1587
6. Tsuchihashi H., Katagi M., Nishikawa M., Tatsuno M., Nishioka H., Nara A., Nishio E., and Petty C. Appl. Spectrosc. 51 (1997) 1796
7. Niemczyk T.M., Delgado-Lopez M.M., and Allen F.S. Anal. Chem. 70 (1998) 2762
8. Skoulika S.G., and Georgiou C.A. Appl. Spectrosc. 55 (2001) 1259
9. Szostak R., and Mazurek S. Analyst 127 (2002) 144
10. Yang H., and Irudayaraj J. J. Pharm. Pharmacol. 54 (2002) 1247
11. Dyrby M., Engelsen S.B., Norgaard L., Bruhn M., and Lundsberg-Nielsen L. Appl. Spectrosc. 56 (2002) 579
12. Skoulika S.G., and Georgiou C.A. Appl. Spectrosc. 57 (2003) 407
13. Szostak R., and Mazurek S. J. Mol. Struct. 704 (2004) 229
14. Hwang M.S., Cho S., Chung H., and Woo Y.A. J. Pharm. Biomed. Anal. 38 (2005) 210
15. Johansson J., Pettersson S., and Folestad S. J. Pharm. Biomed. Anal. 39 (2005) 510
16. Mazurek S., and Szostak R. J. Pharm. Biomed. Anal. 40 (2006) 1225
17. De Beer T.R.M., Vergote G.J., Baeyens W.R.G., Remon J.P., Vervaet C., and Verpoort F. Eur. J. Pharm. Sci. 23 (2004) 355
18. Mazurek S., and Szostak R. J. Pharm. Biomed. Anal. 40 (2005) 1235
19. Tian F., Zeitler J.A., Strachan C.J., Saville D.J., Gordon K.C., and Rades T. J. Pharm. Biomed. Anal. 40 (2006) 271
20. Orkoula M.G., Kontoyannis C.G., Markopoulou C.K., and Koundourellis J.E. J. Pharm. Biomed. Anal. 41 (2006) 1406
21. De Beer T.R.M., Baeyens W.R.G., Ouyang J., Vervaet C., and Remon J.P. Analyst 131 (2006) 1137
22. Hubert P., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., and Valat L. STP Pharma Pratiques 13 (2003) 101
23. Hubert P., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., and Valat L. STP Pharma Pratiques 16 (2006) 28
24. Hubert P., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., and Valat L. STP Pharma Pratiques 16 (2006) 87
25. Hubert P., Nguyen-Huu J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., and Valat L. J. Pharm. Biomed. Anal. 36 (2004) 579
26. Chiap P., Hubert P., Boulanger B., and Crommen J. Anal. Chim. Acta 391 (1999) 227
27. Rbeida O., Christiaens B., Chiap P., Hubert P., Lubda D., Boos K.S., and Crommen J. J. Pharm. Biomed. Anal. 32 (2003) 829
28. Christiaens B., Chiap P., Rbeida O., Cello D., Crommen J., and Hubert P. J. Chromatogr. B 795 (2003) 73
29. Henry de Hassonville S., Chiap P., Liégeois J.F., Evrard B., Delattre L., Crommen J., Piel G., and Hubert P. J. Pharm. Biomed. Anal. 36 (2004) 133
30. Christiaens B., Fillet M., Chiap P., Rbeida O., Ceccato A., Streel B., De Graeve J., Crommen J., and Hubert P. J. Chromatogr. A 1056 (2004) 105
31. Rbeida O., Christiaens B., Hubert P., Lubda D., Boos K.S., Crommen J., and Chiap P. J. Pharm. Biomed. Anal. 36 (2005) 947
32. Jacobs P., Dewé W., Flament A., Gibella M., and Ceccato A. J. Pharmaceut. Biomed. 40 (2006) 294
33. Marini R.D., Chiap P., Boulanger B., Rudaz S., Rozet E., Crommen J., and Hubert P. Talanta 68 (2006) 1166
34. Marini R.D., Servais A.C., Rozet E., Chiap P., Boulanger B., Rudaz S., Crommen J., Hubert P., and Fillet M. J. Chromatogr. A 1120 (2006) 102
35. Esters V., Angenot L., Brandt V., Frédérich M., Tits M., Van Nerum C., Wauters J.N., and Hubert P. J. Chromatogr. A 1112 (2006) 156
36. Bodson C., Dewé W., Hubert P., and Delattre L. J. Pharm. Biomed. Anal. 41 (2006) 783
37. Feinberg M., Boulanger B., Dewé W., and Hubert P. Anal. Bioanal. Chem. 380 (2004) 502
38. Feinberg M., and Laurentie M. Accredit. Qual. Assur. 11 (2006) 3
39. Kuttatharmmakul S., Massart D.L., and Smeyers-Verbeke J. Anal. Chim. Acta 391 (1999) 203
40. Kuttatharmmakul S., Massart D.L., and Smeyers-Verbeke J. Chemometr. Intell. Lab. Syst. 52 (2000) 61
41. Massart D.L., Vandeginste B.G.M., Buydens L.M.C., De Jong S., Lewi P.J., and Smeyers-Verbeke J. Handbook of Chemometrics and Qualimetrics. Part A (1997), Elsevier, Amsterdam, The Netherlands
42. Miller J.N. Analyst 116 (1991) 3
43. Cuadros Rodríguez L., García Campaña A.M., and Bosque Sendra J.M. Anal. Lett. 29 (1996) 1231
44. Vander Heyden Y., Popovici S.T., and Schoenmakers P.J. J. Chromatogr. A 957 (2002) 127
45. Mee R.W. Technometrics 26 (1984) 251
46. Nguyen Minh Nguyet A., van Nederkassel A.M., Tallieu L., Kuttatharmmakul S., Hund E., Hu Y., Smeyers-Verbeke J., and Vander Heyden Y. Anal. Chim. Acta 516 (2004) 87
47. Hartmann C., Smeyers-Verbeke J., Penninckx W., Vander Heyden Y., Vankeerberghen P., and Massart D.L. Anal. Chem. 67 (1995) 4491