A Comparative Study for Evaluation of Five Formulations Of Amlodipine 10 mg Tablets Marketed in Libya


  • Abdulrhman Ahmed Akasha faculty of Pharmacy , University of Tripoli , Tripoli /Libya


Objective: Amlodipine is a calcium channel blocking agent prescribed for treatment of hypertension. However, there are many Amlodipine brands marketed in Libya, with different quality and prices The objective of this study was to evaluate the quality of five commercial Amlodipine (10 mg) products available in the Libyan market such as: Amlor (Pfizer, Morocco), Amlodipine (Bristol, UK), Amlodipine (Blue pharm, Portugal), Amlodipine (Sandoz, UK) and Amady (Ajanta Pharm, India).Methods: To assess quality, all products were examined visually for their organoleptic properties, weight uniformity test, friability, hardness, disintegration test, dissolution test and IR were assayed. We carried out a physical comparison of all Amlodipine tablet products and assessed their quality. The second part of study was carried out a survey upon mentioned formulations of Amlodipine tablets. This survey was including: (45) pharmacist (9) Physicians and (32) Patients volunteers. All the brands are within their expiry dates but there is major difference in price.Results: All the tested five brands were equivalent and complying with the official tests for weight variation, friability, disintegration and dissolution tests. The Hardness of the tablets was failed to pass this test and the range was between 3.8 kg to 11.0 kg of five brands according to USP specifications. The friability test between 0.054% to 0.223%. All formulations were disintegrated between 35 second to 2.15 min. The tested brands were identical according to their dissolution evaluation. The percentage content of active ingredient of five  brands of Metformin tablets showed values within the monograph specifications (75-94.8%). Infra-Red (IR) spectroscopic investigations were revealed no any difference between Amlodipine five brands and showed identical peaks compared to the reference. The simple Survey forwarded to patients , pharmacists and  Physicians to explore their opinion, the most preferable brands is Amlodipine (Bristol) 41%, 44% & 59%respectively. They have chosen Amlodipine according to effectiveness & healthiness. Conclusion: All the available brands in local market of Libya are having, with in the specified quality range and considerably, can be chosen according to good quality and cost, to improve the therapeutic benefit and patient compliance without interchangeability.

Author Biography

Abdulrhman Ahmed Akasha, faculty of Pharmacy , University of Tripoli , Tripoli /Libya

P O Box 13645Tripoli /Libya


Singh RB, Suh IL, Singh VP, Chaithiraphan S, Laothavorn P, Sy RG, Babilonia NA, Rahman AR, Sheikh S, Tomlinson B and Sarraf N: Hypertension and stroke in Asia- Prevalence, control and strategies in developing countries for prevetion. J Hum Hypertens 2000; 14(10-11):749-763

Joshi M, Rao BS and Khan GM: Study of drug use in essential hypertension and their compliance. Kathmandu University Journal of Science, Engineering & Technology 2006; 2(1):1-14

United States Pharmacopeia and National Formulary USP 29–NF 24; The United Pharmacopeial Convention, Inc.: Rockville, MD, 2006.

Dahan A, Miller JM and Amidon GL: Prediction of solubility and permeability class membership- Provisional BCS classification of the world’s top oral drugs. AAPS J 2009; 11(4):740-6

WHO Expert committee on specifications for Pharmaceutical Preparations-WHO Technical Report Series, Annex 8: Proposal to waive in vivo bioequivalence requirements for World Health Organization model list of essential medicines immediate-release, solid oral dosage forms. World Health Organization, Geneva, 2006

Shankar PR, Partha P and Shenoy P: Prescribing pattern of drugs among patient admitted with cardiovascular disorders in the internal medicine ward: Prescribing pattern in inpatients. Internet Journal of Pharmacology 2002; 1(2):1-5

European Pharmacopoeia, 6th ed.; European Directorate for the Quality of Medicines, Council of Europe: Strasbourg, France, 2007.

Drug bank database. Drug card for Amlodipine. http : // www. Drugbank.ca/drugs/DB00381

Ramenskaya GV, Shohin IE, Vasilenko GF and Malashenko EA: In vitro dissolution kinetics of amlodipine tablets marketed in Russia under biowaiver condition. Dissolution Technologies 2010:20-2

Narmada Gy, Mohini K, Prakash RB, Gowrinath DXP and Kumar KS: Formulation, evaluation and optimization of fast dissolving tablets containing amlodipine besylate by sublimation method. Ars Pharm 2009; 50(3): 129-144




How to Cite

Akasha, A. A. (2020). A Comparative Study for Evaluation of Five Formulations Of Amlodipine 10 mg Tablets Marketed in Libya. Innoriginal: International Journal of Sciences, 1–6. Retrieved from https://innoriginal.com/index.php/iijs/article/view/229