A Quality Control Study of Different Brands of Atorvastatin Tablets

ABSTRACT

To be considered a quality drug, a pharmaceutical tablet must meet specific standards. Key quality criteria for any drug in dosage form include safety, potency, efficacy, stability, patient acceptability, and regulatory compliance. These quality aspects must be established during the product development stage, where physical, chemical, and biological specifications are determined to ensure the product meets quality requirements. Our study aimed to determine and compare the percentage labeled claim, quality, and physicochemical characteristics of different brands of atorvastatin tablets using official and unofficial quality control tests. Atorvastatin, an HMG- CoA reductase inhibitor (statin), is essential for preventing hypercholesterolemia and related diseases. Although cholesterol is crucial in daily bodily functions, it can contribute to atherosclerosis development. We selected five brands of atorvastatin tablets (Atorva 40mg, Aztor 40mg, Lipicure 40mg, Lipikind 40mg, Lipvas 40mg) for analysis. Each sample underwent tests for hardness, friability, weight variation, disintegration, dissolution, and assay according to Indian Pharmacopoeia (IP) standards. All brands met the IP limits for hardness (4-8 kg/m²) and also complied with the requirements for weight variation and friability. The disintegration time for all brands was within the 30-minute IP recommendation for film-coated tablets. Each brand exhibited over 85% drug release within 30 minutes, and the content ranged from 90% to 110% of the labeled claim. These findings indicate that all tested atorvastatin brands available in Kerala (Kanjirappally) meet IP quality requirements.

Keywords: Atorvastatin, Quality control, Pharmaceutical Tablets, Physicochemical Characteristics, Hypercholesterolemia, Indian Pharmacopoeia