Stability indicating method development and validation for the simultaneous estimation of rabeprazole sodium and ketorolac tromethamine in bulk and synthetic mixture by RP-HPLC

Abstract

A new, simple, fast and economical stability indicating reverse phase high performance liquid chromatographic method for
the simultaneous determination of Rabeprazole sodium (RPZ) and Ketorolac tromethamine (KTR) in bulk and synthetic
dosage form. Acetonitrile and potassium dihydrogen phosphate buffer was used as a solvent to extract drugs from the
synthetic mixture. Subsequently samples were evaluated directly by simultaneous estimation method by using Inertsil C18
(125×4.6 mm, 5µm) column by isocratic elution by using acetonitrile and potassium dihydrogen phosphate buffer (50:50) as
a mobile phase. The simultaneous determination of RPZ and KTR was carried out with a flow rate of 1 mL/min and UV
detection at 292 nm wavelength. The method was validated according to ICH guidelines with respect to linearity, precision,
accuracy, robustness, ruggedness, specificity and limit of detection and limit of quantification. Further the stability of RPZ
and KTR were accessed using various stressed conditions like acidic, alkaline, oxidative, thermal and photolytic degradations
in bulk drugs (APIs) and formulation. Degradation products produced as a result of stress studies did not interfere with the
detection of RPZ and KTR, so the assay can thus be stability-indicating and can be used for the routine analysis.