Revalidation, determination and development of sildenafil citrate analysis of some brands registered in Sudan

Dissertant

Abd al-Rahim, Abd al-Salam Sami Ali

Thesis advisor

Ibrahim, Mahmud al-Awad

Comitee Members

al-Tuhami, Mahjub Sharif
al-Amin, Babakir Ali

University

Omdurman Islamic University

Faculty

Faculty of Pharmacy

Department

Department of Pharmaceutical Chemistry

University Country

Sudan

Degree

Master

Degree Date

2010

English Abstract

-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.

Main Subjects

Pharmacology

Topics

• Sudan

No. of Pages

70

Table of Contents

• APA
• MLA
• AMA

Language

English

Data Type

Arab Theses

Record ID

BIM-364671