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目的:本文对壬苯醇醚凝胶的处方工艺及质量标准进行了研究。方法:采用高效液相色谱法建立了壬苯醇醚凝胶的含量测定方法,并对其性状、pH值和含量等进行了研究。结果:线性试验的标准曲线方程为Y=63706X+28725r=0.9817,精密度试验RSD=0.05%,稳定性试验RSD=0.38%,重复性试验RSD=1.28%,回收率为97.77%。结论:该方法稳定、合理、可行。
OBJECTIVE: In this paper, the formulation process and quality standards of nonoxynol gel were studied. Methods: The determination method of nonoxynol gel was established by high performance liquid chromatography (HPLC), and its properties, pH value and content were studied. Results: The standard curve equation of the linear test was Y = 63706X + 28725r = 0.9817. The precision test RSD was 0.05%, the stability test RSD was 0.38%, the repeatability test RSD was 1.28%. The recovery rate was 97.77%. Conclusion: The method is stable, reasonable and feasible.