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Revalidation, determination and development of sildenafil citrate analysis of some brands registered in Sudan
مقدم أطروحة جامعية
Abd al-Rahim, Abd al-Salam Sami Ali
مشرف أطروحة جامعية
أعضاء اللجنة
al-Tuhami, Mahjub Sharif
al-Amin, Babakir Ali
الجامعة
جامعة أم درمان الإسلامية
الكلية
كلية الصيدلة
القسم الأكاديمي
قسم الكيمياء الصيدلية
دولة الجامعة
السودان
الدرجة العلمية
ماجستير
تاريخ الدرجة العلمية
2010
الملخص الإنجليزي
-Purpose: This study was done as a quality control testing system to find a universal method of analysis to determine the actual concentration of Sildenafil Citrate in three different brands available and registered in Sudan.
The method will be easy, accurate, reproducible, simple and inexpensive. Method: The identity and content percent of three different brands of Sildenafil Citrate in two brands was assessed through the evaluation of the uniformity of weight, friability test, hardness test, disintegration test, dissolution rate, UV- Spectrophotometry and HPLC using methanol: water 50:50 solvent and mobile phase 35:65 Acetonitrile: Water with 0.1 % TFA in 1 ml / min flow rate. Results: The content of Sildenafil Citrate in two brands was found to be above 120% which is higher than the limit of USP content of pharmaceutical tablet dosage form.
The other brand was found to be within the limits.
All three showed acceptable weight variation range although friability, hardness, dissolution and disintegration variations were obvious.
Infra Red identification spectra showed occurrence and confirmed Sildenafil Citrate structure.
Standard calibration curves were obtained using working standard of Sildenafil Citrate.
These curves were used to calculate the content of Sildenafil Citrate in the different methods used.
The methods used were validated and HPLC method was used to confirm the results obtained by UV- Spectrophotometery analysis.
When the results were compaired, it was found that the UV- Spectrophotometry method gave reliable, easy, inexpensive and applicable results. Conclusion: Up to date, no official method for the analysis of Sildenafil Citrate tablets have been introduced.
No method is reported in the British Pharmacopeia, the United States Pharmacopeia or any other reference pharmacopeia.
It is mandatory to develop, validate and revalidate such a method for the determination, quantitation and quality assurance of such a medicine. As no official reference method is available, it is difficult to determine the actual concentration of the drug in its pharmaceutical form.
Manufacturers of Sildenafil will thus develop in-house methods which vary in sensitivity, selectivity, precision and accuracy. The finding of this research clearly notes that the range of the content of the active ingredient in two brands out of the three is obviously way above limits and the third is below it.
USP states that the tablet assay should range between 90% – 110 %. Sildenafil is now widely prescribed for pulmonary hypertension in children here in Sudan, and it has been used with a high success ratio in this field, so the dosing system should be carefully measured, and without a proper Q.A, Q.C testing of the brands itself, it could lead to very dangerous consequences.
التخصصات الرئيسية
الموضوعات
عدد الصفحات
70
قائمة المحتويات
Table of contents.
Abstract.
Chapter One : Introduction.
Chapter Two : Literature review.
Chapter Three : Materials and methods.
Chapter Four : Results, discussion and conclusion.
References.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Abd al-Rahim, Abd al-Salam Sami Ali. (2010). Revalidation, determination and development of sildenafil citrate analysis of some brands registered in Sudan. (Master's theses Theses and Dissertations Master). Omdurman Islamic University, Sudan
https://search.emarefa.net/detail/BIM-364671
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Abd al-Rahim, Abd al-Salam Sami Ali. Revalidation, determination and development of sildenafil citrate analysis of some brands registered in Sudan. (Master's theses Theses and Dissertations Master). Omdurman Islamic University. (2010).
https://search.emarefa.net/detail/BIM-364671
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Abd al-Rahim, Abd al-Salam Sami Ali. (2010). Revalidation, determination and development of sildenafil citrate analysis of some brands registered in Sudan. (Master's theses Theses and Dissertations Master). Omdurman Islamic University, Sudan
https://search.emarefa.net/detail/BIM-364671
لغة النص
الإنجليزية
نوع البيانات
رسائل جامعية
رقم السجل
BIM-364671
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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