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Stability indicating HPLC method for determination of tadalafil in raw material and pharmaceutical formulation using design of experiments (DoE)
مقدم أطروحة جامعية
مشرف أطروحة جامعية
Urayqat, Ghalib
Shakya, Ashok Kumar
الجامعة
جامعة عمان الأهلية
الكلية
كلية الصيدلة و العلوم الطبية
القسم الأكاديمي
قسم العلوم الصيدلانية
دولة الجامعة
الأردن
الدرجة العلمية
ماجستير
تاريخ الدرجة العلمية
2013
الملخص الإنجليزي
The purpose of this study was to develop a new high performance liquid chromatographic for determination of tadalafil in tablet dosage form.
In the present study a rapid, simple, economical HPLC-PDA procedure has been developed and validated.
The IIPLC method was developed and optimised using Central-composite-design (CCD), after studying the physicochemical properties of tadalafil (solubility, melting point, IR, UV).
The Optimised mobile phase was [55 % buffer (25 mM Na2lIPO4), 45 % acetonitrile and the PH value was adjusted to 7.00 ± 0.05], using orthophosphoric acid 85 %, The flow rate was 1.0 ml / min, signals were detected at wave length of 267nm. The linearity range of the method was from 2 to 24 μg / ml for tadalafil .
LOD was 0.0789 μg / ml for tadalafil, whereas LOQ was 0.239 μg / ml.
The precision of the method was less than 2 % which indicates highly precise result during the study.
The accuracy of the method were ranged from 99.6 %-1 02.79 %.
In conclusion the method presented here is sensitive, rapid, accurate, precise, economic, robust, rugged and selective for the routine analysis of the drug in formulation (tablet) and raw material without changing the chromatographic parameters.
The second part of the work was to develop validate gradient method for separation of impurity (Trans tadalafil), and for studying the effect of stress conditions on raw material and tablet dosage form.
There was no degradation products of tadalafil after exposure to sun light, and sample exposed to stress condition (30°C, 75 % RH, 3months).
Study showed that the products are degraded during stress conditions (after exposure to acidic, alkaline and hydrogen peroxide).
التخصصات الرئيسية
الموضوعات
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
al-Amiri, Amani Rashad. (2013). Stability indicating HPLC method for determination of tadalafil in raw material and pharmaceutical formulation using design of experiments (DoE). (Master's theses Theses and Dissertations Master). Al-Ahliyya Amman University, Jordan
https://search.emarefa.net/detail/BIM-357993
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
al-Amiri, Amani Rashad. Stability indicating HPLC method for determination of tadalafil in raw material and pharmaceutical formulation using design of experiments (DoE). (Master's theses Theses and Dissertations Master). Al-Ahliyya Amman University. (2013).
https://search.emarefa.net/detail/BIM-357993
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
al-Amiri, Amani Rashad. (2013). Stability indicating HPLC method for determination of tadalafil in raw material and pharmaceutical formulation using design of experiments (DoE). (Master's theses Theses and Dissertations Master). Al-Ahliyya Amman University, Jordan
https://search.emarefa.net/detail/BIM-357993
لغة النص
الإنجليزية
نوع البيانات
رسائل جامعية
رقم السجل
BIM-357993
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
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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
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