Abstract

New spectrophotometric method for determination of isoxsuprine hydrochloride in tablets

Author(s): Archana Dolly, Pradeep Mishra, Narendra K.Jain

A new simple, rapid, precise, highly specific and economical spectrophotometric method has been developed for determination of isoxsuprine hydrochloride in pharmaceutical dosage forms. The phenol moiety of isoxsuprine hydrochloride is coupled with diazotized sulfanilic acid, resulting in development of yellowish orange colored complex with an absorptionmaximumat 443.7nm. Beer Lambert’s lawis followed in the concentration range 10-28 g/mL. Limits of detection (LOD) and limits of quantitation (LOQ) are 16.25 and 49.24 g/mLrespectively. The effect of experimental variables such as concentration of color producing reagents and stability of color were investigated to optimize themethod. Themethod was suitably validated following ICHnorms and commonly accepted guidelines for validation of analytical procedures considering the parameters of linearity, accuracy, precision (repeatability and intermediate precision), sensitivity (Sandell’s sensitivity, LOD and LOQ), selectivity and robustness. Statistical analysiswas performed to determine percent relative standard deviation (%R.S.D.), standard deviation (S.D.), standard error (S.E.), and t-values at 95% confidence.