Quality assessment of different brands of atorvastatin tablets available in Riyadh, Saudi Arabia

Ali AlMuhsin; Abdul Ahad; Yousef A Bin Jardan; Mohammad Raish; Ajaz Ahmad; Khalid M Alkharfy; Fahad I Al-Jenoobi

doi:10.1186/s40360-022-00598-y

Quality assessment of different brands of atorvastatin tablets available in Riyadh, Saudi Arabia

BMC Pharmacol Toxicol. 2022 Sep 13;23(1):69. doi: 10.1186/s40360-022-00598-y.

Authors

Ali AlMuhsin^{1

2}, Abdul Ahad³, Yousef A Bin Jardan¹, Mohammad Raish¹, Ajaz Ahmad⁴, Khalid M Alkharfy⁴, Fahad I Al-Jenoobi¹

Affiliations

¹ Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh, 11451, Saudi Arabia.
² Department of Inspection support, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
³ Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh, 11451, Saudi Arabia. abdulahad20@yahoo.com.
⁴ Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, 11451, Saudi Arabia.

Abstract

Background: Hypolipidemic agents have been shown to be helpful in the primary and secondary prevention of cardiovascular disease. Most often, statins are prescribed to treat hyperlipidemia. There are a number of statins available in the market today, but atorvastatin is the most widely prescribed. It is essential that the drugs should have the appropriate amount of active pharmaceutical ingredient and meet the necessary physical properties. The main purpose of the study was to evaluate the quality of different marketed brands of atorvastatin calcium tablets available in Saudi Arabia.

Methods: In this study, innovator product coded as (AS-1) and five generics brands (coded as AS-2 to AS-6) of atorvastatin tablets 20 mg available in Saudi Arabia were evaluated for in vitro dissolution test, weight variations, friability and hardness tests. The analysis of drug was carried out by "high-performance liquid chromatography" (HPLC) method using C₁₈ column (4.6 × 150 mm, 5 μm). The mobile phase was consisted of acetonitrile and HPLC water (pH 2.1, adjusted with orthophosphoric acid) in ratio of 52:48 v/v, the flow rate was 1.0 ml/min. Atorvastatin was detected at a wavelength of 254 nm.

Results: According to the results of the dissolution study, the investigated products released more than 90% of atorvastatin in 15 min. Within 60 min, the brands AS-1, AS-3, AS-5, and AS-6 depicted nearly 100% atorvastatin release, while the brand AS-2 displayed 91.69% drug release. According to our findings, the investigated atorvastatin innovator (AS-1) and generic brands such as AS-2 to AS-6 were of good pharmaceutical quality.

Conclusions: All generic brands of atorvastatin tablets available in the Saudi Arabian market met the pharmacopoeia's consistency checks such as weight variation, friability, hardness and in vitro dissolution. Hence, focusing on their in vitro release properties, it was determined that these brands could be used interchangeably.

Keywords: Atorvastatin; Dissolution; Friability test; HPLC; Tablets; Weight variations.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Atorvastatin
Drugs, Generic
Glycolates
Hydroxymethylglutaryl-CoA Reductase Inhibitors*
Quality Control
Saudi Arabia
Tablets

Substances

Drugs, Generic
Glycolates
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Tablets
Atorvastatin
4-O-carboxymethylascochlorin