9-硝基喜树碱片剂溶出度方法的考察

目的:建立9-硝基喜树碱片剂的溶出度方法,并评价其质量。方法:采用RP-HPLC测定含量。分别对不同溶出介质、转速等条件进行比较,选择合适的溶出条件,考察溶出方法的均一性、稳定性。结果:本测定方法在0.2～6μg·mL~(-1)浓度范围内,特异性、线性良好;回收率、精密度均符合2000年版《中国药典》规定。建立了以0.05％吐温-80-0.1mol·L~(-1)HCl 500mL为溶出介质,温度(37.0±0.5)℃,桨法,转速75r·min~(-1)作为9-硝基喜树碱片剂的溶出方法,该方法均一性、稳定性良好。结论:本试验所建立的9-硝基喜树碱片剂溶出度方法可行,能够客观地反映片剂的溶出情况,从而控制片剂质量。

Investigation on dissolution assay method of 9-nitro-camptothecin tablets

AIM: To establish a dissolution assay method of 9-nitro-camptothecin tablets for determining its quality . METHODS: The content of 9-nitro-camptothecin was determined by RP-HPLC. Different releasing medium and rotational speed was respectively studied to acquire appropriate condition. RESULTS: The HPLC method was shown to be accurate, precise and it had good linearity in the concentration range of 0.2 - 6 g mL-1. The dissolution method was established with paddle method. Dissolution medium was 0.05% Tween-80 0.1 mol L-1 hydrochloric acid, rational speed was 75 r-min-1 and temprature was (37.0 + 0.5) C . CONCLUSION: This method is sensitive, accurate and reliable, and it could be applied to determine the dissolution of 9-nitro-camptothecin tablets.