反相离子对高效液相色谱法测定硫酸羟氯喹片的含量
王玉1，秦斌1，张廷兰2
(1深圳市药品检验所，深圳 518029； 2 重庆医科大学药学系，重庆 400000)
[摘要] 目的：建立硫酸羟氯喹片含量测定的反相离子对高效液相色谱法。方法： 以ODS为固定相，0.05mol.L-1 磷酸二氢钾(含1.5%三乙胺)-0.005 mol.L-1庚烷磺酸钠甲醇溶液(1：1.2，混合后用磷酸调节pH值为7.2)为流动相，流速1.0 mL.min-1，UV检测波长343nm。结果：硫酸羟氯喹在8.0×10-2～5.6×10-1mg.mL-1范围内呈良好的线性关系，r=0.9999。平均回收率99.44%(n=6)。结论：本方法简便、快速、专属，结果准确可靠。
[关键词] 反相离子对高效液相色谱法；硫酸羟氯喹；含量测定
[中图分类号] R976；R972.2 [文献标识码] B [文章编号] 1003-3734(2001)
Determination of hydroxychloroquine sulfate tablets
by RP-IP-HPLC
Wang Yu 1, Qin Bin2 , Zhang Tinglan3
(1 Shenzhen Institute For Drug Control, Shenzhen 518029,China; 2 )
[Abstract] Objective: To establish a method of RP-IP-HPLC determination for hydroxychloroquine sulfate tablets. Methods: Adopting ODS as the stationary phase, 0.05mol.L-1 KH2PO4 (containing 1.5% trithylamine)-0.005mol.L-1 sodium heptanesulfonate methanol solution (1:1.2, mixed and adjusted to pH7.2 with phosphate acid) as the mobile phase, 1.0mL.min-1 flow rate and 243nm detection wavelength. Results: The calibration curve was linear in the concentration range of 8.0×10-2～5.6×10-1mg.mL-1, r=0.9999. The average recovery was 99.44%, (n=6). Conclusion: The method is simple, rapid and specific. The results are accurate and reliable.
[Key words] RP-IP-HPLC; hydroxychloroquine sulfate; assay
[作者简介] 王玉(1954—)，女，副主任药师，主要从事药品检验工作。联系电话：(0755)5874435 。
[参考文献]
[1] Brown RR, Stroshane RM, Renziger D. HPLC assay for hydroxychloroquine and three of its major metabolites desethylhydroxy chloroquine, desethylchloroquine and bidesethylchloroquine in human plasma [J]. J Chromatogr, 1986, 377(2): 454-459.
[2] Morris RG. Estimation of plasma hydroxychloroquine by HPLC with ultraviolet detection [J]. J Chromatogr, 1985,338(2): 422-427.
[3] The United States Pharmacopeial Convention, Inc. USP.24版[S].ISBN 1-889788-03-1. 1999, 841-842., http://www.100md.com
(1深圳市药品检验所，深圳 518029； 2 重庆医科大学药学系，重庆 400000)
[摘要] 目的：建立硫酸羟氯喹片含量测定的反相离子对高效液相色谱法。方法： 以ODS为固定相，0.05mol.L-1 磷酸二氢钾(含1.5%三乙胺)-0.005 mol.L-1庚烷磺酸钠甲醇溶液(1：1.2，混合后用磷酸调节pH值为7.2)为流动相，流速1.0 mL.min-1，UV检测波长343nm。结果：硫酸羟氯喹在8.0×10-2～5.6×10-1mg.mL-1范围内呈良好的线性关系，r=0.9999。平均回收率99.44%(n=6)。结论：本方法简便、快速、专属，结果准确可靠。
[关键词] 反相离子对高效液相色谱法；硫酸羟氯喹；含量测定
[中图分类号] R976；R972.2 [文献标识码] B [文章编号] 1003-3734(2001)
Determination of hydroxychloroquine sulfate tablets
by RP-IP-HPLC
Wang Yu 1, Qin Bin2 , Zhang Tinglan3
(1 Shenzhen Institute For Drug Control, Shenzhen 518029,China; 2 )
[Abstract] Objective: To establish a method of RP-IP-HPLC determination for hydroxychloroquine sulfate tablets. Methods: Adopting ODS as the stationary phase, 0.05mol.L-1 KH2PO4 (containing 1.5% trithylamine)-0.005mol.L-1 sodium heptanesulfonate methanol solution (1:1.2, mixed and adjusted to pH7.2 with phosphate acid) as the mobile phase, 1.0mL.min-1 flow rate and 243nm detection wavelength. Results: The calibration curve was linear in the concentration range of 8.0×10-2～5.6×10-1mg.mL-1, r=0.9999. The average recovery was 99.44%, (n=6). Conclusion: The method is simple, rapid and specific. The results are accurate and reliable.
[Key words] RP-IP-HPLC; hydroxychloroquine sulfate; assay
[作者简介] 王玉(1954—)，女，副主任药师，主要从事药品检验工作。联系电话：(0755)5874435 。
[参考文献]
[1] Brown RR, Stroshane RM, Renziger D. HPLC assay for hydroxychloroquine and three of its major metabolites desethylhydroxy chloroquine, desethylchloroquine and bidesethylchloroquine in human plasma [J]. J Chromatogr, 1986, 377(2): 454-459.
[2] Morris RG. Estimation of plasma hydroxychloroquine by HPLC with ultraviolet detection [J]. J Chromatogr, 1985,338(2): 422-427.
[3] The United States Pharmacopeial Convention, Inc. USP.24版[S].ISBN 1-889788-03-1. 1999, 841-842., http://www.100md.com