Abstract：
CONCLUSIONS: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.
OBJECTIVE: To evaluate the stability of a new, more convenient (<30 minutes for preparation), extemporaneously prepared hydroxyurea solution over 78 days.
METHODS: A high-performance liquid chromatography (HPLC) method using a hydrophilic interaction chromatography (HILIC) column was developed and validated to accurately measure the concentration of hydroxyurea directly from solution without the need for chemical derivatization. Hydroxyurea was dissolved in sterile water in less than 5 minutes to yield a 100-mg/mL solution, which was then diluted by an equal volume of ORA-sweet vehicle to yield a 50-mg/mL extemporaneously prepared solution of hydroxyurea. The solution samples were kept at refrigeration (4 °C), room temperature (26 °C), and elevated temperature (40 °C) for 78 days.
RESULTS: The 50-mg/mL solutions of hydroxyurea in a 1:1 mixture of water and ORA-sweet kept at 4 °C and 26 °C showed no significant loss of potency (<2%) after 78 days. The solutions kept at 40 °C showed greater than 10% loss of potency after 28 days.
CONCLUSIONS: Extemporaneously compounded hydroxyurea 50-mg/mL solutions prepared in a 1:1 mixture of water and ORA-Sweet and stored in amber polypropylene plastic bottles were stable for at least 78 days at room temperature and under refrigeration.
OBJECTIVE: To evaluate the stability of a new, more convenient (<30 minutes for preparation), extemporaneously prepared hydroxyurea solution over 78 days.
METHODS: A high-performance liquid chromatography (HPLC) method using a hydrophilic interaction chromatography (HILIC) column was developed and validated to accurately measure the concentration of hydroxyurea directly from solution without the need for chemical derivatization. Hydroxyurea was dissolved in sterile water in less than 5 minutes to yield a 100-mg/mL solution, which was then diluted by an equal volume of ORA-sweet vehicle to yield a 50-mg/mL extemporaneously prepared solution of hydroxyurea. The solution samples were kept at refrigeration (4 °C), room temperature (26 °C), and elevated temperature (40 °C) for 78 days.
RESULTS: The 50-mg/mL solutions of hydroxyurea in a 1:1 mixture of water and ORA-sweet kept at 4 °C and 26 °C showed no significant loss of potency (<2%) after 78 days. The solutions kept at 40 °C showed greater than 10% loss of potency after 28 days.
CONCLUSIONS: Extemporaneously compounded hydroxyurea 50-mg/mL solutions prepared in a 1:1 mixture of water and ORA-Sweet and stored in amber polypropylene plastic bottles were stable for at least 78 days at room temperature and under refrigeration.
摘要：
结论：为了加快文章的发表，AJHP在接受后尽快在线发布手稿。接受的手稿经过同行评审和复制编辑，但在技术格式化和作者打样之前在线发布。这些手稿不是记录的最终版本，将在以后替换为最终文章（按照AJHP样式格式化并由作者证明）。
目的：为了评估一种新的，更方便（<30分钟准备），临时制备的羟基脲溶液超过78天。
方法：开发并验证了一种使用亲水相互作用色谱（HILIC）柱的高效液相色谱（HPLC）方法，可以直接从溶液中准确测量羟基脲的浓度，而无需化学衍生。羟基脲在不到5分钟的时间内溶解在无菌水中，得到100-mg/mL的溶液，然后用等体积的ORA甜味载体稀释以产生50-mg/mL临时制备的羟基脲溶液。将溶液样品冷藏(4°C),室温(26°C),和升高的温度（40°C）78天。
结果:在4°C和26°C下保存的50-mg/mL的羟基脲在水和ORA-甜味的1:1混合物中的溶液在78天后没有显示出显著的效力损失(<2%)。保持在40°C的溶液在28天后显示大于10%的效力损失。
结论:在水和ORA-Sweet的1:1混合物中制备并储存在琥珀色聚丙烯塑料瓶中的临时复合羟基脲50mg/mL溶液在室温和冷藏下稳定至少78天。
目的：为了评估一种新的，更方便（<30分钟准备），临时制备的羟基脲溶液超过78天。
方法：开发并验证了一种使用亲水相互作用色谱（HILIC）柱的高效液相色谱（HPLC）方法，可以直接从溶液中准确测量羟基脲的浓度，而无需化学衍生。羟基脲在不到5分钟的时间内溶解在无菌水中，得到100-mg/mL的溶液，然后用等体积的ORA甜味载体稀释以产生50-mg/mL临时制备的羟基脲溶液。将溶液样品冷藏(4°C),室温(26°C),和升高的温度（40°C）78天。
结果:在4°C和26°C下保存的50-mg/mL的羟基脲在水和ORA-甜味的1:1混合物中的溶液在78天后没有显示出显著的效力损失(<2%)。保持在40°C的溶液在28天后显示大于10%的效力损失。
结论:在水和ORA-Sweet的1:1混合物中制备并储存在琥珀色聚丙烯塑料瓶中的临时复合羟基脲50mg/mL溶液在室温和冷藏下稳定至少78天。
