YE Aiqin.. Dissolution determination for vitamin B2 in compound vitamin B tablets and its evaluation[J]. JOURNAL OF WEZHOU MEDICAL UNIVERSITY, 2020, 50(5): 406-410.
Abstract：Objective: To establish a method to determine the dissolution of vitamin B2 in compound vitamin B tablets and evaluate the dissolution curves of different samples. Methods: The HPLC was used, and the separation was performed on a CAPCell PAK C18 (4.6 mm×250 mm, 5 μm) column with the mobile phase consisting of the solution containing 2 mmol/L sodium heptane sulfonate and 50 mmol/L ammonium dihydrogen phosphate-acetonitrile (85:15) at a flow rate of 1.0 mL/min. The column temperature was 35 ℃. The detection wavelength was 267 nm. The paddle method was used for the dissolution test of vitamin B2 with 600 mL water as the medium and the rotation rate was set at 75 r/min. Results: Under the chromatographic condition in this study, vitamin B2 (Riboflavin) revealed good linearity within the range of 0.126-5.023 μg/mL (r=0.9999). The average recovery was 103.7%, 100.0% and 99.4% respectively at low, intermediate and high concentration, with the RSD being 0.7%, 1.3%, 0.3%, respectively. The dissolution method was suitable for showing differences in dissolutions among products of different manufacturers. Conclusion: The established HPLC method is simple, which shows good specificity, precision and accuracy. The dissolution method can reflect differences among products of different manufacturers. Some manufacturers should improve the production process, strengthen the dissolution of products to improve the effectiveness of drugs.
