高效液相色谱法测sGC-003片的含量及溶出度

目的：建立可溶性鸟苷酸环化酶（sGC）-003片的含量及溶出度测定方法。方法采用高效液相色谱（HPLC）法测定。HPLC条件如下：色谱柱：Phenomenex Luna C18柱（250 mm×4.6 mm，5μm）；流动相：乙腈-水（40∶60，V/V）；流速：1.0 ml/min；检测波长为：214 nm；柱温：40℃；进样量：20μl（溶出度检测进样量80μl）。溶出度方法采用《中国药典》2015版溶出度测定第二法（桨法），以900 ml pH 4.5醋酸缓冲液、pH 6.8磷酸缓冲液及水为溶出介质，以50、75 r/min作为转速进行溶出条件的筛选。结果该法专属性良好；sGC-003在0.25～50μg/ml范围内线性关系良好（R2=1）；平均回收率为99.58%（RSD为0.75%，n=9）；供试品溶液在12 h内保持稳定（RSD=0.39%，n=8）。确立了以900 ml pH 6.8磷酸缓冲液为溶出介质，桨法转速为50 r/min的溶出方法，30 min时溶出度达80%。结论所选溶出条件适用于sGC-003片溶出度检测。所建HPLC方法简便，灵敏，精密度高，重现性好，专属性强，结果准确，可用于sGC-003片含量测定和溶出度检测。

Content and dissolution determination of sGC-003 tablet by HPLC

Objective To establish a high performance liquid chromatography(HPLC)method for determining the content and dissolution of soluble guanylate cyclase(sGC)-003 tablets. Methods Content and dissolution of sGC-003 tablets were deter?mined by HPLC. Phenomenex Luna C18 column(250 mm×4.6 mm,5μm)was used. The mobile phase was acetonitrile-water(40∶60,V/V), with a flow rate of 1.0 ml/min,and the detection wavelength was set at 214 nm. The column temperature was 40℃and the injection volume was 20μl(injection volume of dissolution was 80μl). Dissolution of sGC-003 tablets was determined by the second method described in Chinese Pharmacopoeia(ChP)2015. 900 ml of pH 4.5 acetic acid buffer,pH 6.8 phosphoric acid buffer and water were used as dissolution media at the rotation speeds of 50 and 75 r/min to select the dissolution condition. Results This method had high specificity. The average recovery was about 99.58%(RSD=0.75%,n=9). And the working solution was stable within 12 h. The calibra?tion curves were had good linearity(R2=1)within the concentration range of 0.25-50μg/ml. The method of dissolution tests for sGC-003 tablets was established that 900 ml pH 6.8 phosphoric acid buffer was used as dissolution medium and paddle rotation speed was 50 r/min. The dissolution would be 80%at 30 min. Conclusion The dissolution condition can be used to determine the dissolution of sGC-003 tablets. The HPLC method is convenient,fast,sensitive and accurate in determining the content and dissolution of sGC-003 tablets.