DOI: 10.21276/sajp.2018.7.9.3

Pages: 414-416

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 theophylline (TEO) for use as TEO cleaning validation on an automatic packaging machine. A chromatographic system comprising 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 UV detector set at 271 nm was used. The TEO retention time was approximately 6.8 min. Regression analysis found that the method was linear over the standard curve range from 0.024 to 120 μg/mL. Inter-day precision and accuracy ranged between 0.20 and 6.59%, and -7.18 and 0.93%, respectively. The precision and accuracy values were under 10% and inside a range of -10% to 10%. Therefore, the lower limit of quantification was inferred to be 0.024 μg/mL. A swabbing procedure using non-woven fabric swabs containing ethanol for disinfection was validated. Mean recoveries from a stainless steel tray and a plastic tray were 102.4 ± 2.2% (mean ± SD, n=3) and 102.5 ± 1.5%, respectively.