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首页> 外文期刊>Analytical methods >Development and validation of a stability-indicating ultra-performance liquid chromatography (UPLC) method for doxycycline hyclate: an optimization of the analytical methodology for a medical countermeasure (MCM)drug
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Development and validation of a stability-indicating ultra-performance liquid chromatography (UPLC) method for doxycycline hyclate: an optimization of the analytical methodology for a medical countermeasure (MCM)drug

机译：盐酸多西环素的稳定性指示超高效液相色谱（UPLC）方法的开发和验证：医学对策（MCM）药物的分析方法的优化

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摘要

Doxycycline hyclate (DOX) is a broad-spectrum anti-infective drug that can be administered for post-exposure prophylaxis (PEP) following exposure to aerosolized spores of Bacillus anthracis and it may be used for acute radiation syndrome (ARS). Because of this public health importance, several federal, state, and local public health and emergency response stakeholders stockpile doxycycline tablets or capsules as medical countermeasures (MCMs). A robust and efficient ultra-performance liquid chromatography (UPLC) method was developed and validated for the simultaneous determination and quantification of doxycycline hyclate and its impurities to enhance the efficiency of control strategies over the product lifecycle. The chromatography was performed on a Waters UPLC system using an Acquity BEH C18 (2.1 × 50 mm, 1.7 μm) column maintained at 55 °C. Doxycycline and its degradation and synthetic impurities were eluted isocratically with 75 mM ammonium acetate, 4 mM EDTA (pH 8.8) and acetonitrile (97?:?3) as the mobile phase with a flow rate of 1.2 mL min?1 and ultraviolet detection at 270 nm. Baseline separation of the analytes was achieved in 6 min. The UPLC method was demonstrated to be stability-indicating after forced degradation studies were conducted on doxycycline hyclate under standard stress conditions of oxidation, photolysis and hydrolysis. The method was validated according to United States Pharmacopoeia (USP) General Chapter 〈1225〉 and was found to be selective, robust, accurate, precise, and reproducible for the simultaneous in vitro quantitation of doxycycline hyclate and its degradation impurities. The method was successfully applied for the quality assessment of current marketed doxycycline hyclate products.
机译：盐酸多西环素（DOX）是一种广谱抗感染药物，可在暴露于炭疽芽孢杆菌的气雾化孢子后用于暴露后预防（PEP），并且可用于急性放射综合症（ARS）。由于这种公共卫生的重要性，一些联邦，州和地方公共卫生与应急响应利益相关者都将多西环素片或胶囊作为医学对策（MCM）。开发了可靠且高效的超高效液相色谱（UPLC）方法，用于同时测定和定量盐酸多西环素及其杂质，以提高产品生命周期内控制策略的效率。使用维持在55℃的Acquity BEH C18（2.1×50mm，1.7μm）柱在Waters UPLC系统上进行色谱。用75 mM醋酸铵，4 mM EDTA（pH 8.8）和乙腈（97？：？3）作为流动相等速洗脱强力霉素及其降解物和合成杂质，流速为1.2 mL min？1，并在270纳米在6分钟内完成了分析物的基线分离。在标准氧化，光解和水解应力条件下，对强力霉素盐酸盐进行强制降解研究后，证明了UPLC方法具有稳定性。该方法已根据美国药典（USP）通则＆ 1225＆进行了验证，被发现具有选择性，鲁棒性，准确性，精确性和可重现性，可用于同时体外定量盐酸多西环素及其降解杂质。该方法已成功应用于目前市场上销售的多西环素盐酸盐产品的质量评估。

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