盐酸头孢克肟固体剂型中盐酸头孢克肟含量的敏感光谱分析方法

Ethiraj Thiruvengadam, R. Ramadoss, M. Amudha
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引用次数: 5

摘要

目的:利用亲水增溶现象对水溶性较差的药物进行光谱分析,避免使用昂贵、对环境有毒性、易挥发和污染的有机溶剂。材料与方法:采用紫外分光光度法,用各种亲水剂稀释头孢克肟进行含量分析。本研究采用20%水杨酸钠(SS)、柠檬酸钠(SC)、乙酸钠(SA)和苯甲酸钠(SB)溶液作为头孢克肟的水相分析。结果与讨论:头孢克肟在SS溶液中浓度为0.5 ~ 2 μg/mL, SC溶液中浓度为5 ~ 30 μg/mL, SA溶液中浓度为5 ~ 50 μg/mL, SB溶液中浓度为0.05 ~ 0.30 μg/mL呈线性关系。然后根据2005年11月国际统一会议指南Q2 (R1)(分析方法的验证:文本和方法)对所提出的方法的准确性和精密度进行验证。该药物对SB溶液的检出限(LOD)和定量限(LOQ)值均较低(LOD = 0.0225471 μg/mL和LOQ = 0.0683246 μg/mL),且在极低浓度范围(0.05 ~ 0.30 μg/mL)符合Beer定律,证明该药物对SB溶液具有较高的敏感性。结论:所有方法简便、成本低、对环境安全、快速、重现性好、对SB溶液灵敏度高。
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Sensitive spectroscopic method for content analysis of cefixime in solid dosage form using hydrotropy phenomenon
Aim: The main aim of this present investigation is to apply the hydrotropic solubilization phenomenon for spectroscopic analysis of poorly water-soluble drugs to avoid the use organic solvents which may be costlier, toxic to environment, volatile, and pollutant. Materials and Methods: A simple ultra violet spectroscopic method was used for the content analysis by diluting the drug cefixime with various hydrotropic agents. In this study, 20% solutions of sodium salicylate (SS), sodium citrate (SC), sodium acetate (SA), and sodium benzoate (SB) were used as hydrotropes for the analysis of cefixime. Results and Discussion: The drug cefixime showed the linearity of 0.5-2 μg/mL in SS, 5-30 μg/mL in SC, 5-50 μg/mL in SA, and 0.05-0.30 μg/mL in SB solution. Then the proposed methods were validated with respect to accuracy and precision as per International Conference of Harmonization guidelines Q2 (R1), November 2005 (Validation of Analytical Procedures: Text and Methodology). The drug showed less limit of detection (LOD) and limit of quantification (LOQ) values (LOD = 0.0225471 μg/mL and LOQ 0.0683246 μg/mL) to SB solution and it obeyed the Beer's law at very low concentration range (0.05-0.30 μg/mL) which proved that the drug has high sensitivity with SB solution. Conclusions: Finally, it was concluded that the all proposed methods were simple, cost-effective, safe to environment, rapid, reproducible, and highly sensitive with SB solution.
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