快速反相高效液相色谱法测定去铁霉素原料药和片剂含量的建立与验证

Santhosh Kumar Ettaboina, Komalatha Nakkala, Nayana Chathalingath
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引用次数: 6

摘要

建立了反相高效液相色谱法测定去铁沙星原料药和片剂的含量。进一步优化的HPLC方法按照现行ICH指南进行验证。色谱柱为Inertsil ODS-3V C18,柱长150mm,柱径4.6mm,粒径5µm,以60:40 v/v比的乙腈和缓冲液(0.05%正磷酸)为流动相,流速1.5mL min-1,在250nm处进行组分检测。HPLC法准确度高,在10.8 ~ 162µg/mL范围内呈线性关系,相关系数>0.999。该方法的准确率达到97%以上。结果表明,目前的方法可以成功地适用于从其原料药和已上市的制剂中对去铁呋司进行评估,这可以有意识地推断出评估其他制剂体系的方法。从线性度、准确度、精密度、LOD、LOQ、稳健性和耐用性等方面对该方法进行了验证。本方法可用于质量控制实验室中去铁霉素的含量测定。
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Development and Validation of Rapid RP-HPLC Method for determination of Deferasirox in Bulk and Tablet Dosage Forms
The reverse phase high performance liquid chromatographic method has been developed for the estimation of Deferasirox in bulk and in tablet dosage form. Further optimized HPLC method was validated as per the current ICH guidelines. The experiment was conducted on a Inertsil ODS-3V C18, 150mm length, 4.6mm ID, and 5µm particle size column using the chromatographic separation was done with 60:40 v/v ratio of Acetonitrile and Buffer (0.05% Orthophosphoric Acid) as the mobile phase at a flow rate of 1.5mL min-1, and detection of component was made at 250nm. The HPLC method was accurate, with linearity ranging from 10.8 to 162µg/mL of Deferasirox, the correlation coeffient >0.999. The method was exposed to a high accuracy of more than 97%. The results disclose the successful applicability of the current process for the estimation of Deferasirox from its drug substance and marketed formulation, which can be consciously inferred to assess the other formulation systems. The developed method was validated in terms of linearity, accuracy, precision, LOD, LOQ, robustness & ruggedness. The proposed method can be helpful in Quality control laboratories for the determination of Deferasirox in the pharmaceutical dosage form.
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