A SIMPLE (HPLC–UV) METHOD FOR THE QUANTIFICATION OF COLCHICINE IN BULK AND ETHOSOMAL GEL NANO-FORMULATION AND ITS VALIDATION
A SIMPLE (HPLC–UV) METHOD FOR THE QUANTIFICATION OF COLCHICINE IN BULK AND ETHOSOMAL GEL NANO-FORMULATION AND ITS VALIDATION
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一种简单的 (HPLC-UV) 方法对散装和醇质凝胶纳米制剂中的秋水仙碱进行定量及其验证
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发表时间：
2017
期刊：
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通讯作者：
Gabriel Onn Kit Loh
中科院分区：
文献类型：
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作者：
Ibrahim M. Abdulbaqi;Y. Darwis;N. Khan;R. Assi;Gabriel Onn Kit Loh
目的：开发并验证一种稳定性指示反相高效液相色谱 (RP-HPLC) 方法，用于测定散装和醇质凝胶纳米制剂中的秋水仙碱。方法：采用不锈钢Hypersil Gold C-18分析柱，尺寸为250 mm x 4.6 mm ID x 5 µm，优化色谱条件。流动相由乙腈和乙酸铵缓冲液（20 mmol/l，pH=4.85）组成，体积比为 32:68。流速设置为 1 ml/min，检测波长为 353 nm。柱保持在 30 °C，进样体积为 10 µl。通过将药物暴露于酸、碱、氧化、热和光的应力降解，研究了秋水仙碱在不同条件下的稳定性。结果：秋水仙碱保留时间5.9 min时，未受到赋形剂、杂质、溶出介质或降解产物的干扰，表明该方法的特异性。检测限 (LOD) 和定量限 (LOQ) 分别为 8.64 ng/ml 和 26.17 ng/ml。该药物在热、酸、氧化和光下表现出良好的稳定性，但在碱条件下观察到明显的降解。该程序的特异性、线性、准确性和精密度均经过验证。结论：成功开发了一种简单、快速、特异且稳定的 HPLC-UV 方法，用于测定纯醇体凝胶中的秋水仙碱。所开发的方法经统计证实是准确、精确且可重复的。
Objective: To develop and validate a stability-indicating reversed phase high-performance liquid chromatography (RP-HPLC) method for the determination of colchicine in bulk and ethosomal gel nano-formulation. Methods: The chromatographic conditions were optimized using stainless steel Hypersil Gold C-18 analytical column with the dimensions of 250 mm x 4.6 mm ID x 5 µm. The mobile phase consisted of acetonitrile and ammonium acetate buffer (20 mmol/l, pH=4.85) in the ratio of 32:68 v/v. The flow rate was set at 1 ml/min and the detection wavelength was 353 nm. The column was maintained at 30 °C and the injection volume was 10 µl. The stability of colchicine in different conditions was investigated by exposing the drug to stress degradation using acid, base, oxidation, heat and light. Results: There was no interference from excipients, impurities, dissolution media or degradation products at the retention time of colchicine 5.9 min indicating the specificity of the method. The limit of detection (LOD) and the limit of quantification (LOQ) were 8.64 ng/ml and 26.17 ng/ml respectively. The drug showed good stability under heat, acid, oxidation and light, but substantial degradation was observed under alkali condition . The procedure was validated for specificity, linearity, accuracy and precision. Conclusion: A simple, rapid, specific and stability-indicating HPLC–UV method for the determination of colchicine in the pure and ethosomal gel was successfully developed. The developed method was statistically confirmed to be accurate, precise, and reproducible.