替米沙坦片的质量和稳定性研究

Study on quality control and stability of telmisartan tablets

目的对替米沙坦片进行质量和稳定性研究。方法采用高效液相色谱法测定替米沙坦,对替米沙坦片中主药含量、溶出度和稳定性进行了考察。结果替米沙坦片45 min溶出度大于标示量的80%,且同一批次内和不同批次间的溶出度均一性良好。对三批样品进行含量测定,检验结果分别为100.3%,100.4%,99.89%,符合标准规定。加速稳定性实验表明样品质量在6个月内未见明显改变,暂定本品有效期为2年。结论替米沙坦片的含量均匀,溶出度重现性良好且产品稳定性好。

Objective To study the quality and stability of telmisartan tablets. Methods The HPLC method was used to determine the contents,the dissolution and the stability of telmisartan tablets. Results The dissolution of telmisartan tablets in 45 min was beyond 80%.Homogeneity of dissolution within the same batch or between different batches was fine.The contents in the three samples were 100.3%,100.4% and 99.89%,which meet the standard requirement.The stability test showed that the drug was stable in 2 years. Conclusion The uniformity of content,the reproducibility of dissolution and the stability of telmisartan tablets are well.