Development and Validation of Stability Indicating Assay Method (Siam) For Rabeprazole in Rabeprazole Sodium Delayed Release Tablets Using HPLC
Author (s): Kirtimaya Mishra1*, Snigdha Rani Behera2, Ch. Gowri Sankar2, Sujit Kumar Martha2
A stability-indicating assay method (SIAM) method was developed for the assay of Rabeprazole (RBZ) in tablet dosage formulations using high performance liquid chromatographic (HPLC). Isocratic separation was achieved on Inertsil ODS 3V (250 x 4.6mm), 5μ, using a mobile phase of Ammonium Acetate buffer (pH 7.0): ACN (50:50), at a flow rate of 1 ml/min and UV detection at 282 nm. retention time of 4.72 min with sharp symmetrical peak. For specificity, linearity, precision, accuracy, precision, robustness, the method was validated. The drug has been subject to conditions of stress, including hydrolysis, oxidation, photolysis and thermal degradation. Full separation was achieved for the parent drug and the degradation products, with a total runtime of 10 min with eluting of the parent compound at approximately 4.72 min. For the study of RBZ in delayed release tablet dosage form, the method was successfully used.
Keywords: Rabeprazole, Stability-indicating assay method, HPLC.