Analytical and Dissolution Method Development and Validation for a Home Formulated Rutin Tablet

Rutin can be classified as flavone, colorant and vitamin. It is highly available in some foods, fruits, vegetables and plant-based beverages. Rutin is highly attracted to the researchers due to its variant beneficial medical effects making rutin used in the treatment of various ailments. Rutin is available in different oral dosage forms such as tablets or capsules either alone or in combination with other active ingredients. Rutin pharmaceutical preparations are widely available in international market as well as Palestinian market. In this study we formulated a 250mg rutin tablet and we developed an easy and simple validated analytical method to quantify rutin in our formulated tablet as well as the internationally marketed Rutin® tablet of Solgar. The method was validated in accordance to international guidelines of the ICH and USP. The dissolution profile of our formulated tablet was also inspected. The shelf and the accelerated stability of the locally formulate tablet was studied. The results clearly show that our developed method was a valid method with a good linearity, precision and accuracy. The validated method was sensitive with LOD and LOQ value of 4.34*10-3 and 0.013mg/ml respectively. The locally formulated rutin tablet was stable under accelerate as well as room temperature for 150 days, only with slight and tolerable drop in the %assay with no detrimental effect on the physical properties of the tablets. The dissolution profile of our locally formulated tablet show slightly better dissolution in phosphate buffer compared with the internationally marketed Rutin® tablet of Solgar. Our study encourages and helps companies that manufacture herbal products especially those present in Palestine to improve their formulated herbals and apply validation analytical methods to check their product quality. In conclusion we succeeded in developing a validated analytical method to quantify rutin in our locally formulated rutin tablet as well as the available rutin formulations present in the local and international markets. Our formulated tablet showed a slight improvement in the dissolution profile and was stable in normal as well as under stress condition