Liquid Chromatographic Methods

Simple, accurate and sensitive liquid chromatographic methods has been developed for the assay, dissolution of ibandronate sodium drug substance in tablet dosage form. The separation was achieved on various columns at ambient temperature. The analytes were monitored by PDA and RID detector. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolytic, thermal and humidity degradation. Considerable degradation was achieved under several conditions. Mass balance was demonstrated in all stress conditions. The method was validated for specificity, precision, linearity, solution stability and accuracy. The average recoveries for ibandronate were in the range of 99.0¿102.0% and the method can be successfully applied for the routine analysis of ibandronate sodium drug substance.