DOI: 10.21276/sajp.2018.7.11.1

Pages: 460-463

Automatic packaging machines are used for preparing one-dose packages with powders, granules, tablets and capsules in pharmacies in Japan. The packaging machines are not dedicated to an individual patient, which leads to contamination of the packaging for the next patient. Cleaning validation for pharmaceutical manufacturing plants is therefore considered essential for packaging machines. The purpose of the present study was to develop and validate an HPLC method for assaying ketotifen fumarate (KTF) for use as KTF cleaning validation on an automatic packaging machine. A chromatographic system comprising a YMC AM12S05-1506WT column, mobile phase of CH3CN:H2O:HClO4:NaClO4=400:600:1:5 (V/V/V/W), flow rate of 1 mL/min, and UV detector set at 300 nm was used. Propyl parahydroxybenzoate (PPB) was used as an internal standard. The KTF and PPB retention times were approximately 6.4 and 10.8 min, respectively. Regression analysis found that the method was linear over the standard curve range from 0.1 to 100 μg/tube. Inter-day precision and accuracy ranged between 1.70 and 22.80%, and-4.37 and 6.50%, respectively. The precision and accuracy values were under 10% and inside a range of -10% to 10% without 0.1 μg/tube. Therefore,