World Journal of
Pharmaceutical and Life Sciences

DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING REVERSE PHASE HPLC METHOD FOR THE DETERMINATION OF RELATED SUBSTANCES IN IXAZOMIB CITRATE DRUG SUBSTANCE

Dr. Navaneeswari Redyam*, Kodavati Ramesh Babu, Muppuri Rajasekhar, Kokkiligadda Deenadayal Rao and Dr. Gopal Vaidyanathan

ABSTRACT

A sensitive, precise, specific, linear and stability indicating a gradient reversed phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for the determination of related substances of Ixazomib Citrate (IXM). The successful chromatographic separation of Ixazomib Citrate from its related substances was achieved on octadecyl silane chemically bonded to porous silica particles stationary phase i.e. Kromosil C18, 150 x 4.6mm, i.d., 5?m column maintained at 29°C and sample cooler: 5°C, using Orthophosphoric acid (OPA) as mobile phase A and mobile phase B composed a mixture of acetonitrile: methanol: isopropyl alcohol (800:120:80 v/v/v) respectively. Wavelength for UV detection: 225 nm, flow rate: 0.8 ml/min and injection volume: 10?l, diluent: mixture of acetonitrile and water in the ratio of (50:50) v/v. The performance of the method was validated according to the ICH guidelines for specificity, linearity, accuracy, precision, limit of quantification and limit of detection. Ixazomib was subjected to stress conditions of thermal, hydrolysis, peroxide and photolytic to observe the degradation products. Limit of detection of impurities were in the range of 0.003%–0.010% indicating the high sensitivity of the developed method. The experiment results are given in detail in this paper.

[Full Text Article]   [Download Certificate]