Sharma N, Rao S S, Vaghela B
Dr. Reddy's Laboratories Ltd., IPDO, Bachupally, Hyderabad.500 090, India.
Indian J Pharm Sci. 2013 Jan;75(1):76-82. doi: 10.4103/0250-474X.113530.
The objective of current investigation was to study the degradation behaviour of eberconazole nitrate and mometasone furoate under different International Conference on harmonisation recommended stress condition using reverse phase high performance liquid chromatographic method and to establish validated stability-indicating high performance liquid chromatographic method to determine purity of eberconazole nitrate and mometasone furoate in presence of its impurities, forced degradation products and placebo in pharmaceutical dosage forms. The method was developed using Hypersil BDS, C18, 150Χ4.6 mm, 5 μ as stationary phase with mobile phase containing a gradient mixture of solvent A and B. 0.01 M phosphate buffer with 0.1% triethyl amine, adjusted pH 7.0 with phosphoric acid was used as buffer. Buffer pH 7.0 was used as solvent A and methanol:acetonitrile in 150:850 v/v ratios were used as solvent B. The eluted compounds were monitored at 240 nm. The run time was 50 min. The developed method was validated as per international conference on harmonization guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness.
当前研究的目的是采用反相高效液相色谱法，研究硝酸依泊康唑和糠酸莫米松在国际协调会议推荐的不同强制条件下的降解行为，并建立经过验证的稳定性指示高效液相色谱法，以测定药物剂型中硝酸依泊康唑和糠酸莫米松在其杂质、强制降解产物和安慰剂存在下的纯度。该方法采用Hypersil BDS C18（150×4.6 mm，5μm）作为固定相，流动相为溶剂A和B的梯度混合物。用含0.1%三乙胺的0.01 M磷酸盐缓冲液，用磷酸调节pH值至7.0作为缓冲液。缓冲液pH 7.0用作溶剂A，甲醇与乙腈以150:850 v/v的比例用作溶剂B。在240 nm处监测洗脱的化合物。运行时间为50分钟。按照国际协调会议指南，对所建立的方法在特异性、线性、检测限、定量限、准确度、精密度和稳健性方面进行了验证。
