Comprehensive Assessment of Degradation Behavior of Simvastatin by UHPLCMS Method, Employing Experimental Design Methodology
المؤلفون المشاركون
Hadzieva Gigovska, Maja
Petkovska, Ana
Acevska, Jelena
Nakov, Natalija
Antovska, Packa
Ugarkovic, Sonja
Dimitrovska, Aneta
المصدر
International Journal of Analytical Chemistry
العدد
المجلد 2018، العدد 2018 (31 ديسمبر/كانون الأول 2018)، ص ص. 1-17، 17ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2018-08-08
دولة النشر
مصر
عدد الصفحات
17
التخصصات الرئيسية
الملخص EN
This manuscript describes comprehensive approach for assessment of degradation behavior of simvastatin employing experimental design methodology as scientific multifactorial strategy.
Experimental design methodology was used for sample preparation and UHPLC method development and optimization.
Simvastatin was subjected to stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation.
Using 2 n full factorial design degradation conditions were optimized to obtain targeted level of degradation.
Screening for optimal chromatographic condition was made by Plackett–Burman design and optimization chromatographic experiments were conducted according to Box-Behnken design.
Successful separation of simvastatin from the impurities and degradation products was achieved on Poroshell 120 EC C18 50 × 3.0 mm 2.7 μm, using solutions of 20 mM ammonium formate pH 4.0 and acetonitrile as the mobile phase in gradient mode.
The proposed method was validated according to International Conference on Harmonization (ICH) guidelines.
Validation results have shown that the proposed method is selective, linear, sensitive, accurate, and robust and it is suitable for quantitative determination of simvastatin and its impurities.
Afterwards, the degradation products were confirmed by a direct hyphenation of liquid chromatograph to ion-trap mass spectrometer with heated electrospray ionization interface.
This study highlights the multiple benefits of implementing experimental design, which provides a better understanding of significant factors responsible for degradation and ensures successful way to achieve degradation and can replace the trial and error approach used in conventional forced degradation studies.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Hadzieva Gigovska, Maja& Petkovska, Ana& Acevska, Jelena& Nakov, Natalija& Antovska, Packa& Ugarkovic, Sonja…[et al.]. 2018. Comprehensive Assessment of Degradation Behavior of Simvastatin by UHPLCMS Method, Employing Experimental Design Methodology. International Journal of Analytical Chemistry،Vol. 2018, no. 2018, pp.1-17.
https://search.emarefa.net/detail/BIM-1166486
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Hadzieva Gigovska, Maja…[et al.]. Comprehensive Assessment of Degradation Behavior of Simvastatin by UHPLCMS Method, Employing Experimental Design Methodology. International Journal of Analytical Chemistry No. 2018 (2018), pp.1-17.
https://search.emarefa.net/detail/BIM-1166486
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Hadzieva Gigovska, Maja& Petkovska, Ana& Acevska, Jelena& Nakov, Natalija& Antovska, Packa& Ugarkovic, Sonja…[et al.]. Comprehensive Assessment of Degradation Behavior of Simvastatin by UHPLCMS Method, Employing Experimental Design Methodology. International Journal of Analytical Chemistry. 2018. Vol. 2018, no. 2018, pp.1-17.
https://search.emarefa.net/detail/BIM-1166486
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1166486
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر