炔诺酮片溶出度测定方法学研究

Determination of the dissolution for Norethisterone Tablets

目的建立炔诺酮片溶出度检查方法。方法采用桨法进行溶出度实验,高效液相色谱法测定介质中药物含量。结果溶出度检查方法为桨法,以5g.L-1十二烷基硫酸钠溶液500mL为溶出介质,转速为75r.min-1,取样时间为45min(薄膜衣片)或60min(糖衣片)。含量测定方法的线性方程为Y=64 743 X-208(r=1.000 0),在0.12～1.84μg.mL-1质量浓度范围内线性关系良好(r=1.000);A企业样品平均回收率为100.1%,RSD为1.3%,B企业样品平均回收率为100.8%,RSD为0.7%。结论该方法准确可靠,适用于该制剂的质量控制。

Objective To establish a method for the determination of the dissolution rate of Norethisterone Tablets.Methods The method Ⅱ described in the appendix ⅩC of Chinese Pharmacopoeia（2010） was carried out and the HPLC method was adopted for detection of the dissolution rate.Results 500 mL of 5 g·L-1 SDS was used as a solvent with rotating speed of a paddle at 75 r·min-1.The sampling time was 45 min（film coated tablets） or 60 min（sugar-coat tablets） and was quantitatively analyzed by HPLC.The regression equation of norethisterone was Y=64 743X-208（r=1.000 0）.The average recovery of norethisterone was 100.1%,with RSD of 1.3%（samples of factory A） and 100.8%,with RSD of 0.7%（samples of factory B）.Conclusion The method is accurate and suitable for the dissolution determination for Norethisterone Tablets.