PHARMACEUTICAL EVALUATION AND POST-MARKET SURVEILLANCE STUDY OF THREE BRANDS OF LISINOPRIL TABLETS IN SUDAN

Fatehalrahman F. Magbool; Abdrhman Mahmoud Gamil; Alaa I. M. Ahmed; Anasseya HA Hassan; Nagwa J. M. Ali

doi:10.22270/ujpr.v6i1.536

Fatehalrahman F. Magbool Department of Pharmaceutics, Faculty of Pharmacy, Al-Neelain University, Khartoum, Sudan.
Abdrhman Mahmoud Gamil Department of Pharmaceutics, Faculty of Pharmacy, Al-Neelain University, Khartoum, Sudan.
Alaa I. M. Ahmed Department of Pharmaceutics, Faculty of Pharmacy, Al-Neelain University, Khartoum, Sudan.
Anasseya HA Hassan Department of Pharmaceutics, Faculty of Pharmacy, Al-Neelain University, Khartoum, Sudan.
Nagwa J. M. Ali Department of Pharmaceutics, Faculty of Pharmacy, Al-Neelain University, Khartoum, Sudan.

10.22270/ujpr.v6i1.536

Keywords:

Hypertension, Lisinopril, Pharmaceutical quality, Similarity factor, UV Spectrophotometric

Abstract

Background: Lisinopril is a type of angiotensin-converting enzyme (ACE) inhibitor that used to treat high blood pressure (hypertension) in adults and children. The safety and efficacy of drug products can be assured when their quality is consistent and reproducible. To ensure the requisite quality, pharmaceutical companies are required to test their products during and after manufacturing and at various intervals during the shelf life of the product.

Methods: The aim of this study was to study and evaluate the physicochemical and pharmaceutical parameters in order to confirm the pharmaceutical quality of the generic Lisinopril tablet formulations available in Sudan. Evaluation was done based on the compendia physicochemical and pharmaceutical evaluation parameters. Different brands of Lisinopril 5mg tablets purchased randomly from drug stores, and coded Z, L and A, were assayed for weight uniformity, friability, hardness, disintegration, dissolution rate using standard physical methods, and also the similarity is studied to compare brand of originator to the generic products. Their percentage drug contents were determined using standard UV Spectrophotometric method.

Results: All the brands being studied comply the pharmacopoeial specifications for weight uniformity, friability, disintegration and dissolution. The dissolution profile shows more than 80 % release in 30 minutes. Additionally, all brands should similarity factor above 50% and therefore to be consider as similar. Quantitatively, all the three brands being tested do complied with the pharmacopoeial specifications for drug content.

Conclusion: Hence this study will serve as a tool in assessing the pharmaceutical quality and to monitor post market quality, safety and efficacy of Lisinopril tablet formulations.

Peer Review History:

Received 6 December 2020; Revised 8 January 2021; Accepted 11 February; Available online 15 March 2021

Academic Editor: Prof. Dr. Gorkem Dulger, Duzce University, Turkey, gorkemdulger@yandex.com

Received file: Reviewer's Comments:

Average Peer review marks at initial stage: 5.5/10

Average Peer review marks at publication stage: 7.0/10

Reviewer(s) detail:

Prof. Dr. A. Hakan AKTAŞ, Süleyman Demirel University, Faculty of Science and Art, Department of Chemistry, Isparta-Turkey, hakanaktas@sdu.edu.tr

Dr. Vijay Kumar Singh, Institute of Pharmacy, Bundelkhand University, Jhansi, India, vijayquantum@gmail.com

Dr. Hayriye Eda Şatana Kara, Gazi University, Turkey, eda@gazi.edu.tr