Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method

Shubhangi M. Pawar; Laxman D. Khatal; Satish Y. Gabhe; Sunil R. Dhaneshwar

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Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method

机译：建立普拉克索的固有稳定性并开发出经过验证的稳定性，表明采用LC–UV和LC–MS方法

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Pramipexole belongs to a class of nonergot dopamine agonist recently approved for the treatment of early and advanced Parkinson's disease. A validated specific stability indicating reversed-phase liquid chromatographic method has been developed for the quantitative determination of pramipexole in bulk as well as in pharmaceutical dosage forms in the presence of degradation products. Forced degradation studies were performed by exposition of drug to hydrolytic (acidic and basic), oxidative and photolytic stress conditions, as defined under ICH guideline Q1A (R2). Significant degradation was observed under hydrolytic, oxidative and photolytic conditions and the degradation products formed were identified by LC–MS.

机译：普拉克索属于一种最近被批准用于治疗早期和晚期帕金森氏病的非麦角多巴胺激动剂。已开发出一种经过验证的特定稳定性指示反相液相色谱方法，用于定量测定存在降解产物的散装普拉克索和药物剂型中的普拉克索。通过将药物暴露于ICH准则Q1A（R2）规定的水解（酸性和碱性），氧化和光解应力条件下，进行了强制降解研究。在水解，氧化和光解条件下观察到显着降解，并且通过LC-MS鉴定了形成的降解产物。

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《Journal of Pharmaceutical Analysis》 |2013年第2期|共9页
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Shubhangi M. Pawar; Laxman D. Khatal; Satish Y. Gabhe; Sunil R. Dhaneshwar;
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中图分类药学;
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1. Establishment of inherent stability of pramipexole and development of validated stability indicating LC-UV and LC-MS method [J] . Shubhangi M.Pawar, Laxman D.Khatal, Satish Y.Gabhe, 药物分析学报（英文） . 2013,第002期

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6. Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method [O] . Shubhangi M. Pawar, Laxman D. Khatal, Satish Y. Gabhe, 2013

机译：建立普拉克索的固有稳定性并开发出经过验证的稳定性表明采用LC–UV和LC–MS方法
7. Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method [O] . Pawar Shubhangi M., Khatal Laxman D., Gabhe Satish Y., 2013

机译：建立普拉克索的固有稳定性并开发出经过验证的稳定性，表明采用LC–UV和LC–MS方法

Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method

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