Quality Standard Establishment And Stability Inspection Of Ibuprofen Orally Disintegrating Tablets

Ibuprofen is one of the non-steroidal anti-inflammatory drugs (NSAIDs), which are used to relieving pain, inflammation and fever. Ibuprofen shows good curative effects and less se rious side effects from clinical practice. Orally disintegrating tablet is a new dosage form and not listed in any pharmacopoeia . At present, a legal quality standard of Ibuprofen orally dis- integrating tablet is not established. According to current technical requirements of the orally disintegrating tablets issued by FDA and SFDA, a method was proposed in this paper for de- termination of Ibuprofen and related substances, and the dissolution and identification of ac- tive integrants by high-performance liquid chromatography (HPLC). The validation of analy- tical methods was finished. The determination method of disintegrating time of Ibuprofen orally disintegrating tablets was also proposed. Based on results of sample stability test, the quality control system was established.The experimental results showed that HPLC method excelled the traditional method in quality control of Ibuprofen orally disintegrating tablets. HPLC method had merits in separa- ting size, sensitivity and elimination of interference of the excipients and solvents. This me- thod was a simple and accurate assay and suitable for quality control of the Ibuprofen orally disintegrating tablets.