Development and validation of a novel stability-indicating reversed-phase high-performance liquid chromatography method for assay of loratadine and determination of its related compounds

Journal of AOAC International

Volumn 93, Issue 3, 2010, Pages 891-903

  Lu, Jun ^a   Wei, Vu Chien ^a   Markovich, Robert J ^a   Rustum, Abu M ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG PRODUCTS; GRADIENT METHODS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; STABILITY; SULFUR COMPOUNDS;

ACTIVE PHARMACEUTICAL INGREDIENTS; INTERNATIONAL CONFERENCE ON HARMONIZATIONS; OVER THE COUNTERS; RELATED COMPOUNDS; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; RP-HPLC METHOD; SODIUM ACETATE; STABILITY-INDICATING;

SODIUM DODECYL SULFATE;

EID: 77954730496     PISSN: 10603271     EISSN: None     Source Type: Journal    
DOI: 10.1093/jaoac/93.3.891     Document Type: Article

References (55)

1. Kay, G.G., & Harris A.G. (1999) Clin. Exp. Allergy 29, 147-150
2. Radwanski E., Hilbert J., & Synchowitz S. (1987) J. Clin. Pharmacol. 27, 530-533
3. Hilbert J., Radwaski E., & Weglein R. (1987) J. Clin. Pharmacol. 27, 694-698
4. Ghoneim M.M., Mabrouk M.M., Hassanein A.M., & Tawfik A. (2001) J. Pharm. Biomed. Anal. 25, 933-939
5. Martens J. (1995) J. Chromatogr. B 673, 183-188
6. Martens J., Meyer F.P., Troeger, U., & Franke T. (1995) Br. J. Clin. Pharmacol. 39, 560P-561P
7. Johnson R., Christensen J., & Lin, C.C. (1994) J. Chromatogr. B 657, 125-131
8. Kunicki P.K. (2001) J. Chromatogr. B 755, 331-335
9. Amini, H., & Ahmadiani A. (2004) J. Chromatogr. B 809, 227-230
10. Yin O.Q.P., Shi, X., & Chow M.S.S. (2003) J. Chromatogr. B 796, 165-172
11. Xu, X J., Shang E.X., Qiu F.R., Mao, G.G., & Xiang B.R. (2004) YaoXueXueBao39, 123-126
12. Zhong D., & Blume, H. (1994) Pharmazie 49, 736-739
13. Vlase L., Imre S., Muntean D., & Leucuta S.E. (2007) J. Pharm. Biomed. Anal. 44, 652-657
14. Salem, I.I., Idrees J., & Al Tamimi J.I. (2004) J. Pharm. Biomed. Anal. 34, 141-151
15. Yang L., Clement R.P., Kantesaria B., Reyderman L., Beaudry F., Grandmaison, C., Di Donato L., Masse R., & Rudewicz P.J. (2003) J. Chromatogr. B 792, 229-240
16. Naidong W., Addison T., Schneider T., Jiang, X., & Halls T.D.J. (2003) J. Pharm. Biomed. Anal. 32, 609-617
17. Zhang Y.F., Chen, X.Y., Zhong D.F., & Dong Y.M. (2003) Acta Pharmacol. Sin. 24, 715-718
18. Naidong W., Bu, H., Chen Y.-L., Shou W.Z., Jiang, X., & Halls T.D.J. (2002) J. Pharm. Biomed. Anal. 28, 1115-1126
19. Sutherland F.C.W., de Jager A.D., Badenhorst D., Scanes T., Hundt, H.K.L., Swart K.J., & Hundt A.F. (2001) J. Chromatogr. A 914, 37-43
20. Yang L., Mann T.D., Little D., Wu N., Clement R.P., & Rudewicz P.J. (2001) Anal. Chem. 73, 1740-1747
21. Chen J., Zha Y.Z., Gao K.P., Shi, Z.Q., Jiang, X.G., Jiang W.M., & Gao, X.L. (2004) Pharmazie 59, 600-603
22. Mabrouk M.M., El-Fatatry, H.M., Hammad S., & Wahbi A.A.M. (2003) J. Pharm. Biomed. Anal. 33, 597-604
23. El Ragehy N.A., Badawey A.M., & El-Khateeb S.Z. (2002) .J. Pharm. Biomed. Anal. 28, 1041-1053
24. Mahgoub, H., Gary A.A., El-Yazbi F.A., El-Sayed M.A., & Youssef R.M. (2003) J. Pharm. Biomed. Anal. 31, 801-809
25. Radhakrishna T., Narasaraju A., Ramakrishna M., & Satyanarayana A. (2003) J. Pharm. Biomed. Anal. 31, 359-368
26. Gazy A.A., Mahgoub, H., E1-Yazbi F.A., El-Sayed M.A., & Youssef R.M. (2002) J. Pharm. Biomed. Anal. 30, 859-867
27. Basavaiah K., & Charan V.S. (2002) ScienceAsia 28, 359-364
28. Nogowska M., Zajac M., & Muszalska, I. (2000) Chem. Anal. 45, 681-688
29. Onur F., Yücesoy, C., Dermi S., Kartal M., & Kökdil, G. (2000) Talanta 51, 269-274
30. Lin, Z.H. (1996) Yaowu Fenxi Zazhi 16,53
31. Indrayanto, G., Darmawan L., Widjaja S., & Noorrizka, G. (1999) J. Planar Chromatogr.-Mod. TLC 12, 261-264
32. Koury N.E., & Bebawy L.I. (1999) J. Pharm. Biomed. Anal. 20, 671-679
33. El-Ragehy N.A., Badawy A.M., & Khateeb S.Z. (1995) Anal. Lett. 28, 2363-2378
34. Rajput S.J., & Vyas A.G. (1998) Indian Drugs 35, 352-355
35. Squella J.A., Sturm J.C., Diaz M.A., Pessoa, H., & Nuñez-Vergara L.J. (1996) Talanta 43, 2029-2035
36. Fernández, H., Rupérez F.J., & Barbas, C. (2003) .J. Pharm. Biomed. Anal. 31, 499-506
37. Mikuš., Kubačák P., Valášková I., & Havránek E. (2004) Pharmazie 59, 260-262
38. Capella-Priró M.E., Bossi A., & Esteve-Romero J. (2006) Anal. Biochem. 352, 41-49
39. El-Sherbiny D.T., El-Ragehy N.A., Belal F.F., & Hansen S.H. (2007) .J. Pharm. Biomed. Anal. 43, 1236-1242
40. Qi M., Wang P., & Geng Y. (2005) J. Pharm. Biomed. Anal. 38, 355-359
41. Krishna Reddy K.V.S.R., Moses Babu J., Ravindra Kumar Y., Vishnu Reddy S., Kishore Kumar M., Eswaraiah S., Rama Subba Reddy K., Sayanarayana Reddy M., Vijaya Bhaskar B., Dubey P.K., & Vyas K. (2003) J. Pharm. Biomed. Anal. 32, 29-39
42. Rupérez F.J., Fernández, H., & Barbas, C. (2002) J. Pharm. Biomed. Anal. 29, 35-41
43. Radhakrishna T., Satyanarayana J., & Satyanarayana A. (2002) Indian Drugs 39, 342-347
44. British Pharmacopoeia (2008) Ph. Eur. 6.0 Monograph 2124: Loratadine, Council of Europe, Strasbourg, France
45. U.S. Pharmacopeia and National Formulary (2007) USP Monograph: Loratadine, U.S. Pharmacopeial Convention, Rockville, MD
46. Sun J., Wang, G., Wang W., Zhao S., Gu Y., Zhang J., Huang M., Shao F., Li, H., Zhang, Q., & Xie, H. (2005) J. Pharm. Biomed. Anal. 39, 217-224
47. Ramanathan R., Su A.-D., Alvarez N., Blumenkrantz N., Chowdhury S.K., Alton K., & Patrick J. (2000) Anal. Chem. 72, 1352-1359
48. Xiao K.P., Xiong Y., Liu F.Z., & Rustum A.M. (2007) .J. Chromatogr.A 1163, 145-156
49. Xiao K.P., Chien D., Markovich R., & Rustum A.M. (2007) J. Chromatogr.A 1157, 207-216
50. Lu J., Wei Y.-C., Markovich R.J., & Rustum A.M. (2010) J. Liq. Chromatogr. Relat. Technol. 33, 603-614
51. Snyder L.R., Dolan J.W., & Carr P.W. (2007) Anal. Chem. 79, 3254-3262
52. Snyder L.R., Dolan J.W., & Carr P.W. (2004) J. Chromatogr. A 1060, 77-116
53. Snyder L.R., & Dolan J.W. (2004) LCGC N Am. 22, 1146, 1148, 1151-1152
54. Validation ofAnalytical Procedures, Q2(R1) Definitions and Terminology (2005) International Conference on Harmonization, Geneva, Switzerland, http://www.ich.org.
55. Validation ofAnalytical Procedures, Q2B Methodology (1996) International Conference on Harmonization, Geneva, Switzerland, http://www.ich.org.