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首页> 外文期刊>The Journal of automatic chemistry >Development and Validation of a Versatile UPLC-PDA Method for Simultaneous Determination of Paracetamol, Tizanidine, Aceclofenac, and Nimesulide in Their New Combinations
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Development and Validation of a Versatile UPLC-PDA Method for Simultaneous Determination of Paracetamol, Tizanidine, Aceclofenac, and Nimesulide in Their New Combinations

机译：同时测定扑热息痛，替扎尼定，醋氯芬酸和尼美舒利新组合的通用UPLC-PDA方法的开发和验证

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摘要

A simple, rapid, and validated UPLC method was developed for the simultaneous quantitation of paracetamol (PAR), tizanidine (TIZ), aceclofenac (ACF), and nimesulide (NIM) either in pure forms or in their different tablet dosage forms. Chromatographic separation was attained on an ACQUITY UPLC? BEH C18 column (100?mm?×?2.1?mm, 1.7?m) with a mobile phase consisting of 20?mM phosphate buffer (pH 7.0)?:?acetonitrile in the proportion (60?:?40 /) isocratically pumped at a flow rate of 1.25?mL·min?1, and detection was monitored at 305?nm. All analytes were separated simultaneously at a retention time (tr) of 1.42, 2.31, 3.63, and 5.62?min for PAR, TIZ, ACF, and NIM, respectively, with a total run time less than 6.0?min. The proposed method was validated according to ICH guidelines with respect to accuracy, precision, linearity, limit of detection, limit of quantitation, and robustness. Linearity was obtained over a concentration range of 81.25–487.5, 0.5–3.5, 25–150, and 25–150?μg·mL?1 for PAR, TIZ, ACF, and NIM, respectively. The development method can be successfully employed in QC laboratories for the routine analysis of the investigated drugs in their new combination.
机译：开发了一种简单，快速且经过验证的UPLC方法，用于以纯形式或不同片剂剂型同时定量对乙酰氨基酚（PAR），替扎尼定（TIZ），醋氯芬酸（ACF）和尼美舒利（NIM）。在ACQUITY UPLC上完成色谱分离。 BEH C18色谱柱（100？mm××2.1？mm，1.7？m），流动相由等度泵入比例为（60？：？40 /）的20？mM磷酸盐缓冲液（pH 7.0）？：？乙腈组成流速为1.25？mL·min？1，并在305？nm处检测。 PAR，TIZ，ACF和NIM的保留时间（tr）分别为1.42、2.31、3.63和5.62？min，同时分离所有分析物，总运行时间少于6.0？min。该方法根据ICH指南在准确性，精度，线性，检测限，定量限和鲁棒性方面进行了验证。 PAR，TIZ，ACF和NIM的浓度范围分别为81.25–487.5、0.5–3.5、25–150和25–150µg·mL？1，得到线性。该开发方法可以成功地用于QC实验室，对所研究药物的新组合进行常规分析。

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