Mass Compatible Liquid Chromatography Method for Degradation Study of Aliskiren Hemifumarate and Identification of Adduct Impurity in Presence of Lacatose Excipient

A rapid, specific and accurate stability indicating liquid chromatographic method compatible with Mass Spectrophotometer has been developed for Aliskiren Hemifumarate. The LC method is carried out on a Hypersil BDS C8 150*4.6 mm maintained at 25°C. The mobile phase consisted of 0.1 M ammonium acetate adjusted to pH 6.5±0.05 and mixed with Methanol in ratio of 375:200 v/v. A gradient programme used with acetonitrile with flow rate of 1.0 mL/min, with ʎmax 278 nm. The chromatographic separation is obtained with Aliskiren retention time at about 18 minutes and it is linear in the range 1 – 4 ppm ( 0.05% - 0.2 % of Test concentration). The specificity and stability-indicating capability of the method are proven through degradation studies, which also showed that, there is no interference of degradation products and peak due to excipients with main peak.  Developed method was used for identification of Aliskiren Lactose adduct impurity. The method partially validated for its intended use and can be applicable for stability study.