Baiju Mathews

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.

Clopidogrel is an orally administered medicine that lowers the risk of heart disease. The production process is defined by drug quality, and every pharmaceutical business aims for it, although it is often difficult to attain. The purpose of this study was to look at the quality control parameters of several commercially available Clopidogrel tablets. Four distinct marketed brands of Clopidogrel 75 mg tablets available in the Mangalore market were collected from different pharmacies in Mangalore city to examine the quality. Weight variation, hardness, thickness, and friability, among other quality indicators, were determined according to established protocols. Then there was the in-vitro dissolution test, potency, and disintegration time. All of the brands met the requirements of the Pharmacopoeia since they had a weight fluctuation range that was acceptable. All brands were less than 1% friable, and there were no significant differences in disintegration times, since they all dissolved within 15 minutes. In terms of dissolution profile, all brands had an acceptable dissolving time, releasing more than 60% of the drug in less than 45 minutes. All brands’ hardness fell inside the range. All of the brands also meet the potency requirements. This investigation found that the majority of commercially available Clopidogrel pills in Mangalore are of good quality and meet pharmacopoeia requirements.