Comparative In-Vitro Evaluation of Different Commercially Brands of Rabeprazole Sodium Tablets
Abstract
A comparative in-vitro evaluation was carried out on ten different commercially brands of rabeprazole sodium tablets (20 mg) to determine their pharmaceutical equivalence and quality attributes. This study determined critical quality parameters including weight variation, hardness, friability, disintegration time, and dissolution profiles following standard pharmacopoeial protocols. The tablets exhibited hardness values ranging from 3.0 to 7.0 kg/cm², with friability between 0.60% and 2.0%. Disintegration times varied significantly among brands, with four formulations showing delayed disintegration beyond 49 minutes. All brands had shown acceptable drug release profiles, achieving 95-98.9% dissolution within 45 minutes in phosphate buffer pH 6.8. Brands R2, R4, R7, and R8 displayed highest mechanical properties and dissolution characteristics, while R1, R3, R5, and R6 showed extended disintegration times despite meeting dissolution requirements. The dissolution efficiency ranged from 95% to 98.9%, with R7 showing maximum drug release. Statistical analysis revealed significant variations in disintegration patterns among different brands. Accelerated stability studies confirmed product integrity over 30 days at 40°C ± 2°C and 75% ± 5% RH. These results indicate that while all tested formulations meet pharmacopoeial standards, considerable variations exist in their in-vitro performance characteristics, which may influence therapeutic outcomes
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