A stability indicating reversed-phase HPLC method has been developed and
subsequently validated for simultaneous estimation of pantoprazole present as
pantoprazole sodium sesquihydrate (PSS), and itopride hydrochloride from their
combination product. The proposed RP-HPLC method utilizes a Phenomenex
®
C18, 5 µm,
250 mm X 4.6 mm i.d. column, mobile phase consisting of phosphate buffer and
acetonitrile in the proportion of 55:45 (v/v) with apparent pH adjusted to 5.0, and UV
detection at 289.0 nm using a UV detector. PAN, ITH and their combination drug product
were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the
stressed samples were analyzed by the proposed method. The described method was
linear over a range of 4-20 µg/mL for PAN and 15-75 µg/mL for ITH. The mean
recoveries were 100.02 and 99.88 for PAN and ITH, respectively. Chromatographic peak
purity data of PAN and ITH indicated no co-eluting peaks with the main peaks of drugs
which demonstrated the specificity of assay method for their estimation in presence of
degradation products. The proposed method can be useful in the quality control of
combination drug products.
