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Determination of anti-FXa potency in heparin sodium and inositol nicotinate cream by micro-chromogenic substrate method |
LI Xiang MA Hongda WU Qiong HOU Mingxiao▲ |
Department of Pharmacy, General Hospital of Shenyang Military Command, Liaoning Province, Shenyang 110016, China |
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Abstract Objective To establish a method for determination of anti-FXa potency in heparin sodium and inositol nicotinate cream. Methods The emulsion was broken. The anti-FXa potency was determined by micro-chromogenic substrate method and biological test statistics method. Results The determination method was established for anti-FXa potency in heparin sodium and inositol nicotinate cream. The linear range of anti-FXa was during 0.0250-0.1020 IU/mL (r=0.996). The average recovery in three levels was 99.5% (RSD=1.92%, n=9). The ratio of potency was during 0.9-1.1 for anti-FXa and anti-FⅡa. Conclusion The method is accurate and reproduceable. It can be used for the determination of anti-FXa potency in order to control the quality of heparin sodium and inositol nicotinate cream.
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