半水左氧氟沙星和乳酸环丙沙星的 pH 溶解度曲线

Pub Date : 2024-05-01 DOI:10.46542/pe.2024.243.105110

Dewi Isadiartuti, Retno Sari, Dini Retnowati, Risma Dama Yanti, Violyta Ade Gunawan, Oki Yudiswara

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引用次数: 0

摘要

背景：左氧氟沙星和环丙沙星是常用的氟喹诺酮类抗生素，因其广谱活性而具有多种治疗潜力。左氧氟沙星和环丙沙星通常用作肠外用药的活性药物成分（API），它们是两性化合物，具有对 pH 值敏感的溶解性。这一特性可能会影响左氧氟沙星和环丙沙星的安全性和疗效，尤其是在肠外剂型中：本研究旨在评估半水合左氧氟沙星和乳酸环丙沙星在 pH 值为 3.0 至 8.0 的缓冲溶液中的溶解度：溶解度测试在 pH 值为 0.02 M、离子强度 (µ) 为 0.2 的缓冲溶液中进行。称量若干原料药样品后，超声处理 15 分钟。溶液在 150 rpm 和 30 ± 0.5°C 的温度下搅拌，直至达到平衡（4 小时）。使用紫外可见分光光度计观察原料药浓度：结果：在实验 pH 值范围内，半水合左氧氟沙星和乳酸环丙沙星的溶解度范围分别为 44.39 至 70.66 毫克/毫升和 0.23 至 243.00 毫克/毫升：本研究得出结论，半水合左氧氟沙星和乳酸环丙沙星的溶解度因 pH 值降低而增加。

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The pH-solubility profiles of levofloxacin hemihydrate and ciprofloxacin lactate

Background: Levofloxacin and ciprofloxacin are popular fluoroquinolone antibiotics that offer diverse therapeutic potentials due to their broad-spectrum activity. Levofloxacin and ciprofloxacin, commonly used as active pharmaceutical ingredients (API) in parenteral form, are amphoteric compounds with pH-sensitive solubility. This characteristic may affect the safety and efficacy of levofloxacin and ciprofloxacin, especially in the parenteral dosage forms. Objective: This study aims to assess the solubility of levofloxacin hemihydrate and ciprofloxacin lactate in buffer solutions with pH ranging from 3.0 to 8.0. Method: The solubility test was conducted in a 0.02 M buffer pH solution featuring an ionic strength (µ) of 0.2. After weighing several API samples, ultrasonication was carried out for 15 minutes. The solution was agitated at 150 rpm and 30 ± 0.5°C until it reached equilibrium (four hours). The API concentration was observed using a UV-Vis spectrophotometer. Result: The solubility ranges of levofloxacin hemihydrate and ciprofloxacin lactate were 44.39 to 70.66 mg/mL and 0.23 to 243.00 mg/mL, respectively, within the experimental pH range. Conclusion: This study concluded that levofloxacin hemihydrate and ciprofloxacin lactate solubility were increased due to decreasing pH medium.

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