Study on dissolution determination of Oxaprozin capsules by HPLC
SUN Ying1, ZHAO Yaping1, LI Qunlin2, SONG Lijuan1
1. Department of Drug Control, Hubei Institute for Drug Control,Wuhan 430075, China; 2. Pharmacy Department,Hubei Provincial Corp Hospital of Chinese People's Armed Police Force, Wuhan 430060, China
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.
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SUN Ying, ZHAO Yaping, LI Qunlin, SONG Lijuan. Study on dissolution determination of Oxaprozin capsules by HPLC. Med. J. Chin. Peop. Armed Poli. Forc., 2021, 32(12): 1075-1078.
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2021, Vol. 32 
