摘要
目的建立盐酸米诺环素胶囊、片剂含量及有关物质的测定方法.方法采用HPLC法,使用C8柱,以0.2 mol·L-1醋酸铵-N,N二甲基甲酰胺-四氢呋喃(600∶398∶2 ,内含0.01 mol·L-1乙二胺四乙酸二钠)为流动相,检测波长280 nm.结果盐酸米诺环素在0.1～2.0 mg·ml-1范围内呈良好的线性关系(r=0.9999),胶囊的平均加样回收率为99.9%,RSD＝0.6%(n=9);片剂的平均加样回收率为100.5%,RSD＝0.7%(n=9).结论所建方法准确、灵敏度高,能有效地控制产品质量.
OBJECTIVE To establish a method for determining capsule and tablet of Minocycline hydrochloride and its related substances. METHODS An HPLC method was adopted with a Cs column. The mobile phase was 0.2 mol· L^- 1 ammonium acetate - dimethyl formamide - tetrahydrofuran （600： 398 ： 2, containing 0.01 mol· L^- 1 EDTA - 2Na ）, The wavelength for detection was set at 280 urn. RESULTS The standard curve of Minocycline hydrochloride was linear in the range of 0.1 to 2.0 mg· ml^- 1 （ r = 0.9999）. The average recovery of capsule was 99.9% with RSD of 0.6%（n =9）.The average recovery of tablet was 100.5% with RSD of 0.7%（n =9）.CONCLUSION The method is accurate, highly specific and widely applicable . Through the investigation of the samples from the whole country, it is shown that the method developed in this study can be applicable to control the quality of products.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2005年第6期531-534,共4页
West China Journal of Pharmaceutical Sciences
作者简介
高燕霞，女，副主任药师，从事药物分析工作。
