Abstract��OBJECTIVE To study the content determination method of crotamiton. METHODS The quantitative mass balance method, HPLC external standard method and nuclear magnetic resonance(QNMR) were used to determine the content of crotamiton, respectively. The accuracy of the three methods was evaluated. RESULTS The contents of crotamiton were 99.2%,102.9% and 99.1% respectively as determined by the three different methods. CONCLUSION Because the ultraviolet absorption coefficients of cis- and trans-crotamiton might be different, the current pharmacopoeia method, ie, using integrated peak areas to calculate the content, is questionable. QNMR method can measure the contents of cis- and trans-crotamiton respectively, so it can be a complementary method to establish the reference standard.
Ch. P( 2010) Vol ��( �й�ҩ��2010 ���. ����) [S]. 2010: 318;APPENDIX �� K;APPENDIX XIX F
[2]
IZUMOTO S I, MACHIDA Y S, NISHI H, et al. Chromatography of crotamiton and its application to the determination of active ingredients in oinments [J]. J Pharm Biomed Anal,1997,15(9-10):1457-1466.
[3]
FENG Y C, LIU S Y , HU C Q. Establishment of national reference standard of biapenem[J]. Chin J Antibiot(�й���������־),2010, 35(9): 679-683.
[4]
ZHANG Q,LI X D,YANG H X. Application of nuclear magnetic resonance in pharmaceutical standards[J]. Chin J Pharm Anal(ҩ�������־),2012,32(3):545-549.
[5]
WANG Q F , HANG T J , ZHANG Z X. Determination of the enantiomeric composition of naproxen by NMR with a chiral lanthanide shift reagents[J]. J China Pharm Univ(�й�ҩ�ƴ�ѧѧ��),1999, 30(1):31-33.
[6]
SHEN W B,WANG Q F, LIAO H P. Study of NMR method for stereoisomeric determination of pharmaceuticals ��. Felodipine[J]. Chin J Pharm Anal(ҩ�������־),1996,16(4):230-233.
[7]
TAN Y, YANG M S, HU A X, et al. Quantitative analysis and study of perillartine isomers by NMR[J]. Flavour Fragrance Cosmetics(�����㾫��ױƷ),2006,10(5):13-16.
[8]
SHEN W B, ZHANG C,WANG Q F. NMR Studies of tetrahydroberberine enantiomers[J]. J China Pharm Univ(�й�ҩ�ƴ�ѧѧ��),1997,28(3):132-135.
[9]
HOLZGRABE U, DIEHL B W K, WAWER I. NMR Spectroscopy in pharmacy [J]. J Pharm Biomed Anal, 1998, 17(4-5): 557-616.
[10]
GUO R. The influence of electronic effect, three- dimensional effect and solvent effect on ultraviolet spectrum[J].J Yuxi Teacher Coll(��Ϫʦ���ߵ�ר��ѧУѧ��),2000,16(3):56-57.
[11]
ZHANG Y J, LIU X P. Studies of NMR acquisition parameters for quantitative analysis of drugs[J]. Chin J Magn Resonance (����ѧ��־),2007,24(3):289-295.
2015, Vol. 50 
