高效液相色谱法测定奥沙普秦胶囊溶出度的研究

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Abstract Objective To determine the dissolution rate of Oxaprozin capsules by high performance liquid chromatography, and to provides the basis for the quality control. Methods According to the Standard of oxaprozin tablets and oxaprozin enteric-coated capsules in the Chinese Pharmacopoeia (2020,partII),Japanese Orange Book and the United States Pharmacopoeia,we methodologically validated the dissolution method of oxaprozin capsules,and established a method for dissolution determination of oxaprozin capsules by HPLC. Results An HPLC method was used, and the saparation was performed on a Inertsil C₈(250 mm×4.6 mm;5 μm) column with the mobile phase consisting of 0.1% phosphoric acid solution- acetonitrile(55∶45) at a flow rate of 1.0 ml/min. The column temperature was 35 ℃.The Injection volume was 20 μl. The dissolution test was performed by basket method with 0.05 mol/l Monopotassium phosphate buffer solution (pH7.4) of 1000 ml as dissolution medium and rotating speed of 100 r/min, dissolution time 45 minutes, limit 75%. Conclusions The estsblished method of dissolution determination by HPLC showed good specificity,precision and accuracy, and can be used as the basis for the dissolution quality standard of oxaprozin capsules.

Key words： oxaprozin capsules high performance liquid chromatography dissolution

Received: 08 November 2021

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	SUN Ying
	ZHAO Yaping
	LI Qunlin
	SONG Lijuan

Cite this article:

SUN Ying,ZHAO Yaping,LI Qunlin等. Study on dissolution determination of Oxaprozin capsules by HPLC[J]. Med. J. Chin. Peop. Armed Poli. Forc., 2021, 32(12): 1075-1078.

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http://journal08.magtechjournal.com/Jwk_wjyx/EN/ OR http://journal08.magtechjournal.com/Jwk_wjyx/EN/Y2021/V32/I12/1075

[1]	李公春,王利叶,牛亮峰,等.奥沙普秦的合成[J].化学工程师,2015,29(10):9-10.
[2]	Dallegri F, Bertolotto M, Ottonello L. A review of the emerging profile of the anti-inflammatory drug oxaprozin[J]. Expert Opinion Pharmacother, 2005, 6(5):777-785.
[3]	朱常贵. 评价奥沙普秦肠溶片治疗类风湿关节炎的疗效和安全性[J]. 现代医学与健康研究电子杂志,2018,2(16):198-199.
[4]	王天学,张敏娟,魏文芝,等.盐酸吗啡片溶出度测定方法的改进[J].西北药学杂志,2018,33(6):789-793.
[5]	张惠珍,黄诺哲,黄莹.坎地氢噻片的溶出度测定[J].广东化工,2021,48(9):242-243.
[6]	刘萍,胡利敏,田洪年,等.HPLC法测定水合羟基化头孢克洛杂志研究[J/OL].中国抗生素杂志.(2020-09-30)[2021-06-07].https://doi.org/10.13461/j.cnki.cja.007186.
[7]	徐文峰,金鹏飞,徐硕,等.高效液相色谱法测定依普利酮片的溶出度[J].中国医院药学杂志,2019,39(4):353-355.
[8]	陈东华,李智颖,邹瑜,等.泮托拉唑钠肠溶片溶出度的研究[J].中国药品标准,2020,21(1):36-41.
[9]	沈川,程义,曾令高,等.阿莫西林胶囊溶出度测定方法研究[J]. 中国药业,2021,30(5):59-62.
[10]	Ruben M, Maggi O, Patricia M, et al. A new principal component analysis-based approach for testing “similarity” of drug dissolution profiles[J].Eur J Pharm Sci, 2008, 34(1):66-77.
[11]	张伟,刘建芳,赵彩霞.口服固体制剂溶出度测定方法的研究与应用进展[J]. 中国医药导报,2016,13(3):48-50.
[12]	国家药典委员会. 中华人民共和国药典(二部)[M]. 北京:中国医药科技出版社,2020:1674-1675.
[13]	U. S. Pharmacopeia National Formulary. USP39 NF34[M]. Baltimore: United Book Press, Inc., 2016: 5196-5197.
[14]	原国家食品药品监督管理总局.关于发布普通口服固体制剂溶出度试验技术指导原则和化学药物(原料药和制剂)稳定性研究技术指导原则的通告(2015年第3号)[EB/OL]. (2015-02-05). https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20150205120001100.html.
[15]	郭宏,周新腾,邱树勇,等.pH对奥沙普秦渗透性的影响[J]. 沈阳药科大学学报,2001,18(6):409-410.