Repaglinide tablets and quality standards of.doc

 PAGE \* MERGEFORMAT 16 Repaglinide tablets and quality standards of Of: D Steel, Long Xiao-Ying, Fei Yuan, Chen Li, Zhong Xueping, Ye Meihua, Zhu Shuqiang [Abstract] Objective To prepare repaglinide tablets, and establish quality standards. Approach to dissolution rate, hardness, appearance as an indicator, the orthogonal test L9 (34) selected the best prescription; by HPLC with reggae Chennai column content, content uniformity and dissolution. Results The optimized composition of repaglinide tablets: microcrystalline cellulose: PVP K30: CCNa the mass ratio of 74:5:20; determination of study methodology Results: repaglinide concentration in the 9.905 ~ 99.05 g mL-1 in the range of linear relationship between peak area showed good recovery was 100.83%, RSD was 0.98% (n = 9), the lowest detection limit was 2.0 ng lower limit of quantification was 8.0 ng; content uniformity was 6.84; 30 min cumulative dissolution of 98.25%. Conclusion reasonable prescription screening, preparation process is simple and feasible, preparation of repaglinide tablets meet the quality of preparation requirements. [Keywords:] repaglinide tablets; orthogonal test; HPLC; content; quality standards Abstract: Objective To prepare repaglinide tablets and establish the quality standard. Methods Orthogonal array testing was conducted to optimize the formulation with the indices of dissolution rate, appearance and hardness. HPLC method was established to measure content, content uniformity and dissolution rate. Results The optimum formulation of repaglinide tablets was MCC: PVP K 30: CCNa = 74:5:20, and a good linear relationship was obtained in the range of 9.905 ~ 99.05 g mL-1, r = 1.0 000. The average recovery was 100.83 %, with RSD 0.98% (n = 9). The LOD was 2.0 ng and the LOQ was 8.0 ng, content uniform was 6.84, and dissolution was 99.25%. Conclusion The reasonable formulation was obtained and preparation was simple, and the prepared tablets met the requirements. Keyword