Development and Validation of a Specific Stability Indicating High Performance Liquid Chromatographic Methods for Related Compounds and Assay of Solifenacin Succinate
المؤلفون المشاركون
Reddy, K. Subhash
Reddy, B. V. Rami
Rambabu, C.
Raman, N. V. V. S. S.
Reddy, B. Srinivasa
المصدر
العدد
المجلد 2013، العدد 2013 (31 ديسمبر/كانون الأول 2013)، ص ص. 1-10، 10ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2012-12-04
دولة النشر
مصر
عدد الصفحات
10
التخصصات الرئيسية
الملخص EN
Gradient, reverse phase liquid chromatographic methods were developed separately for the related compounds and solifenacin succinate, an active pharmaceutical ingredient used for the treatment of overactive bladder.
Gradient LC method was employed for related compounds.
The mobile phase-A contains a 0.01 M phosphate buffer pH: 3.5±0.05 with orthophosphoric acid (88%) and mobile phase-B contains a mixture of acetonitrile and water in the ratio of 90 : 10(v/v).
The flow rate was 1.0 mL/minute, column temperature was kept at 35°C, and detection was monitored at 220 nm.
In the developed HPLC method the resolution between solifenacin succinate and its closely eluting impurity, that is, solifenacin N-oxide was found to be greater than 3.0.
The drug was subjected to stress conditions such as hydrolysis, oxidation, photolysis, and thermal degradation.
Considerable degradation was found to occur in only oxidative stress condition.
Degradation product formed during oxidative stress condition was found to be impurity-C and it can be identified by LC-MS.
The stress samples were assayed against a qualified reference standard and the mass balance was found close to 99.5%.
The developed RP-LC method was validated as per ICH guidelines.
We also developed LC-MS/MS method for determination and identification of these impurities in solifenacin succinate.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Reddy, B. V. Rami& Reddy, B. Srinivasa& Raman, N. V. V. S. S.& Reddy, K. Subhash& Rambabu, C.. 2012. Development and Validation of a Specific Stability Indicating High Performance Liquid Chromatographic Methods for Related Compounds and Assay of Solifenacin Succinate. Journal of Chemistry،Vol. 2013, no. 2013, pp.1-10.
https://search.emarefa.net/detail/BIM-470048
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Reddy, B. V. Rami…[et al.]. Development and Validation of a Specific Stability Indicating High Performance Liquid Chromatographic Methods for Related Compounds and Assay of Solifenacin Succinate. Journal of Chemistry No. 2013 (2013), pp.1-10.
https://search.emarefa.net/detail/BIM-470048
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Reddy, B. V. Rami& Reddy, B. Srinivasa& Raman, N. V. V. S. S.& Reddy, K. Subhash& Rambabu, C.. Development and Validation of a Specific Stability Indicating High Performance Liquid Chromatographic Methods for Related Compounds and Assay of Solifenacin Succinate. Journal of Chemistry. 2012. Vol. 2013, no. 2013, pp.1-10.
https://search.emarefa.net/detail/BIM-470048
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-470048
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