反相高效液相色谱法测定富马酸喹硫平片的含量
付崇铭，王汝展
(山东省精神卫生中心，济南250014)
[摘要] 目的：建立富马酸喹硫平片含量测定的反相高效液相色谱法。方法：采用Hypersil ODS-C18 (250mm×4.6mm,5μm)色谱柱，以甲醇-0.5%三乙胺(78:22，冰醋酸调pH至7~8)为流动相，流速1 mL.min-1，检测波长254nm，柱温室温，进样量10μL 。考察了流动相不同配比、不同pH对富马酸喹硫平色谱行为的影响。结果：富马酸喹硫平与片剂辅料及其他杂质可完全分离；在10~100µg.mL-1浓度范围内线性关系良好(r=0.9986)，平均回收率99.7%，RSD=1.5%。结论：该方法操作简便，结果准确，专属性强。可用于富马酸喹硫平片的含量测定。
[关键词] 富马酸喹硫平；反相高效液相色谱法；含量测定
[中文分类号] R971.41 [文献标识码] B [文章编号] 1003-3734(2001)-20010228
RP-HPLC determination of quetiapine fumarate in tablets
FU Chong-ming, WANG Ru-zhan
(Shandong Mental Health Center，Jinan 250014, China)
[Abstract] Objective: To establish a RP-HPLC method for determination of quetiapine fumarate in tablets. Method: Instruments,reagents,and conditions adopted in the analysis were: a Hypersil ODS-C18 column(250mm×4.6mm,5μm) ,a UV detector of 254nm, a mobile phase of MeOH:0.5%triethylamine=78:22, its pH was adjusted to 7~8 with glacial acetic acid, a flow rate of 1.0 mL.min-1 and a column temperature of room temperature. Results: Quetiapine fumarate and tablets excipients can be completely separated with a liner range of 10~100µg.mL-1 and correlation coefficients of 0.9986. The average recovery was 99.7% with a RSD of 1.5%. Conclusion: A simple, accurate, selective and suitable method for determination of quetiapine fumarate in tablets was established.
[Key words] quetiapine fumarate; RP-HPLC; content determination
[作者简介] 付崇铭(1962—)，男，副主任药师，现主要从事临床药学及高效液相色谱分析。联系电话： (0531)8932677-240
[参考文献]
[1] Mconville BJ, Arvanitis LA, Thyrum PT, et al. Pharmacokinetics,tolerability,and clinical effectiveness of quetiapine fumarate:an open-label trial in psychotic disorders[J]. J Clin Psychiatry, 2000, 61(4): 252-260.
[2] 国家药典委员会.中华人民共和国药典[S].2000版二部北京:化学工业出版社,2000.附录32-34., http://www.100md.com
(山东省精神卫生中心，济南250014)
[摘要] 目的：建立富马酸喹硫平片含量测定的反相高效液相色谱法。方法：采用Hypersil ODS-C18 (250mm×4.6mm,5μm)色谱柱，以甲醇-0.5%三乙胺(78:22，冰醋酸调pH至7~8)为流动相，流速1 mL.min-1，检测波长254nm，柱温室温，进样量10μL 。考察了流动相不同配比、不同pH对富马酸喹硫平色谱行为的影响。结果：富马酸喹硫平与片剂辅料及其他杂质可完全分离；在10~100µg.mL-1浓度范围内线性关系良好(r=0.9986)，平均回收率99.7%，RSD=1.5%。结论：该方法操作简便，结果准确，专属性强。可用于富马酸喹硫平片的含量测定。
[关键词] 富马酸喹硫平；反相高效液相色谱法；含量测定
[中文分类号] R971.41 [文献标识码] B [文章编号] 1003-3734(2001)-20010228
RP-HPLC determination of quetiapine fumarate in tablets
FU Chong-ming, WANG Ru-zhan
(Shandong Mental Health Center，Jinan 250014, China)
[Abstract] Objective: To establish a RP-HPLC method for determination of quetiapine fumarate in tablets. Method: Instruments,reagents,and conditions adopted in the analysis were: a Hypersil ODS-C18 column(250mm×4.6mm,5μm) ,a UV detector of 254nm, a mobile phase of MeOH:0.5%triethylamine=78:22, its pH was adjusted to 7~8 with glacial acetic acid, a flow rate of 1.0 mL.min-1 and a column temperature of room temperature. Results: Quetiapine fumarate and tablets excipients can be completely separated with a liner range of 10~100µg.mL-1 and correlation coefficients of 0.9986. The average recovery was 99.7% with a RSD of 1.5%. Conclusion: A simple, accurate, selective and suitable method for determination of quetiapine fumarate in tablets was established.
[Key words] quetiapine fumarate; RP-HPLC; content determination
[作者简介] 付崇铭(1962—)，男，副主任药师，现主要从事临床药学及高效液相色谱分析。联系电话： (0531)8932677-240
[参考文献]
[1] Mconville BJ, Arvanitis LA, Thyrum PT, et al. Pharmacokinetics,tolerability,and clinical effectiveness of quetiapine fumarate:an open-label trial in psychotic disorders[J]. J Clin Psychiatry, 2000, 61(4): 252-260.
[2] 国家药典委员会.中华人民共和国药典[S].2000版二部北京:化学工业出版社,2000.附录32-34., http://www.100md.com