DOI: 10.21276/sajp.2018.7.10.2

Pages: 438-441

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 aim of the present study was to develop and validate an HPLC method for assaying acetaminophen (AAP) for use as AAP cleaning validation on an automatic packaging machine. A chromatographic system comprised of a YMC AM12S05-1506WT column, mobile phase of CH3CN:H2O:HClO4:NaClO4=100:900:1:5 (V/V/V/W), flow rate of 1 mL/min, and a UV detector set at 271 nm, was used. Theophylline (TEO) was used as an internal standard. The AAP and TEO retention times were approximately 6.2 and 6.8 min, respectively. Regressio analysis found that the method was linear over the standard curve range from 0.02 to 40 mg/tube. Inter-day precision and accuracy ranged between 0.34 and 26.86%, and -1.93 and 2.44%, respectively. The precision and accuracy values were under 10% and inside a range of -10% to 10% without 0.02 mg/tube. Therefore, the lower limit of quantification was considered to be 0.02 mg/tube.