Abstract：
Universal microchip isotachophoresis (μITP) methods were developed for the determination of cationic and anionic macrocomponents (active pharmaceutical ingredients and counterions) in cardiovascular drugs marketed in salt form, amlodipine besylate and perindopril erbumine. The developed methods are characterized by low reagent and sample consumption, waste production and energy consumption, require only minimal sample preparation and provide fast analysis. The greenness of the proposed methods was assessed using AGREE. An internal standard addition was used to improve the quantitative parameters of μITP. The proposed methods were validated according to the ICH guideline. Linearity, precision, accuracy and specificity were evaluated for each of the studied analytes and all set validation criteria were met. Good linearity was observed in the presence of matrix and in the absence of matrix, with a correlation coefficient of at least 0.9993. The developed methods allowed precise and accurate determination of the studied analytes, the RSD of the quantitative and qualitative parameters were less than 1.5% and the recoveries ranged from 98 to 102%. The developed μITP methods were successfully applied to the determination of cationic and anionic macrocomponents in six commercially available pharmaceutical formulations.
摘要：
开发了通用微芯片等速电泳（μITP）方法，用于测定以盐形式销售的心血管药物中的阳离子和阴离子大分子成分（活性药物成分和抗衡离子），氨氯地平苯磺酸盐和培多普利。所开发的方法的特点是试剂和样品消耗低，废物产生和能源消耗，只需要最少的样品制备和提供快速分析。使用AGREE评估了所提出方法的绿色度。使用内标添加来改善μITP的定量参数。根据ICH指南对所提出的方法进行了验证。线性度,精度,评估了每种研究分析物的准确性和特异性,且符合所有设定的验证标准.在存在基质和不存在基质的情况下观察到良好的线性，相关系数至少为0.9993。所开发的方法可以精确和准确地测定所研究的分析物，定量和定性参数的RSD小于1.5％，回收率为98％至102％。开发的μITP方法已成功用于测定六种市售药物制剂中的阳离子和阴离子大分子组分。
