Design and strategy approach for spectrofluorimetric determination of midodrine in tablets: Application to content uniformity testing

摘要

An innovative, sensitive and uncomplicated spectrofluorimetric method was developed then validated for the determination of midodrine in either its authentic pure form or its tablets. This method is found on the reaction occurring between the aliphatic primary amino moiety of midodrine with ninhydrin/phenylacetaldehyde reagents, using a Torell and Steinhagen buffer at pH 7, producing a highly fluorescent product whose fluorescence intensity was measured at 450 nm after excitation at 388 rim. A calibration curve was constructed that showed that the linear range was (0.5-6.0 mu g/ml). The LOD and LOQ values were 0.16 and 0.48 mu g/ml respectively. The proposed approach was validated in accordance with ICH guidelines and successfully adapted for the determination of midodrine in its tablets. Eventually, the presented method was adapted for studying the content uniformity test as stated in United States Pharmacopeia (USP) guidelines.