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A novel HPLC-DAD method for simultaneous determination of alfuzosin and solifenacin along with their official impurities induced via a stress stability study; investigation of their degradation kinetics.
Analytical Methods ( IF 2.7 ) Pub Date : 2020-06-19 , DOI: 10.1039/d0ay00822b Mahmoud A Tantawy 1 , Soheir A Weshahy 1 , Mina Wadie 1 , Mamdouh R Rezk 1
Analytical Methods ( IF 2.7 ) Pub Date : 2020-06-19 , DOI: 10.1039/d0ay00822b Mahmoud A Tantawy 1 , Soheir A Weshahy 1 , Mina Wadie 1 , Mamdouh R Rezk 1
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Stability and impurity profiling are in high demand to guarantee the potency, safety and efficacy of new formulations along with their shelf-life. In this study, stability testing of alfuzosin (ALF) and solifenacin (SOL) in their newly co-formulated capsules was conducted under different stress conditions. The obtained degradation products were structurally elucidated and found to be their official impurities, namely; ALF impurity-D and SOL impurities-A, E & I. A selective and reliable stability-indicating HPLC method was developed for assaying the cited drugs along with three of those official impurities. Chromatographic separation was accomplished within 8 minutes using a XBridge® C18 column as the stationary phase and acetonitrile : phosphate buffer (pH 8) : triethylamine (60 : 40 : 0.02, by volume) as the mobile phase at a flow rate of 1.3 mL min−1. Quantification of the analytes was performed at 210 nm using a diode array detector through which peak purity was assessed. The proposed method was validated as per ICH guidelines and it was successfully applied for the determination of the cited drugs in their combined pharmaceutical formulation with percent recoveries of 100.47 and 100.15 for ALF and SOL, respectively. Moreover, the proposed method was exploited for the assessment of the two drugs' stability in Solitral® capsules under accelerated storage conditions. The method was further extended for studying the degradation kinetics of the two drugs.
中文翻译：
一种新颖的HPLC-DAD方法，用于同时测定通过应力稳定性研究诱导的阿夫唑嗪和索非那新及其官方杂质；研究它们的降解动力学。
为了确保新配方的效力，安全性和有效性以及其保质期，对稳定性和杂质分析的要求很高。在这项研究中，在不同的压力条件下进行了阿夫唑嗪（ALF）和索非那新（SOL）在其新配制的胶囊中的稳定性测试。对得到的降解产物进行结构澄清，发现是它们的官方杂质，即：ALF杂质D和SOL杂质A，E和I。开发了一种选择性和可靠的稳定性指示HPLC方法，用于测定所引用的药物以及其中的三种官方杂质。使用XBridge®C18色谱柱作为固定相并使用乙腈：磷酸盐缓冲液（pH 8）：三乙胺（体积比为60：40：0.02）作为流动相，在8分钟内完成色谱分离。-1。使用二极管阵列检测器在210 nm处对分析物进行定量，通过该检测器评估峰纯度。所提出的方法已按照ICH指南进行了验证，已成功地用于组合药物配方中所引用药物的测定，其中ALF和SOL的回收率分别为100.47和100.15。此外，该方法被用来评估两种药物在加速储存条件下在Solitral®胶囊中的稳定性。该方法进一步扩展到研究两种药物的降解动力学。
更新日期：2020-07-09
中文翻译：
一种新颖的HPLC-DAD方法，用于同时测定通过应力稳定性研究诱导的阿夫唑嗪和索非那新及其官方杂质；研究它们的降解动力学。
为了确保新配方的效力，安全性和有效性以及其保质期，对稳定性和杂质分析的要求很高。在这项研究中，在不同的压力条件下进行了阿夫唑嗪（ALF）和索非那新（SOL）在其新配制的胶囊中的稳定性测试。对得到的降解产物进行结构澄清，发现是它们的官方杂质，即：ALF杂质D和SOL杂质A，E和I。开发了一种选择性和可靠的稳定性指示HPLC方法，用于测定所引用的药物以及其中的三种官方杂质。使用XBridge®C18色谱柱作为固定相并使用乙腈：磷酸盐缓冲液（pH 8）：三乙胺（体积比为60：40：0.02）作为流动相，在8分钟内完成色谱分离。-1。使用二极管阵列检测器在210 nm处对分析物进行定量，通过该检测器评估峰纯度。所提出的方法已按照ICH指南进行了验证，已成功地用于组合药物配方中所引用药物的测定，其中ALF和SOL的回收率分别为100.47和100.15。此外，该方法被用来评估两种药物在加速储存条件下在Solitral®胶囊中的稳定性。该方法进一步扩展到研究两种药物的降解动力学。
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