DOI: 10.21276/sajp.2019.8.1.2

Pages: 11-14

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 pranlukast (PLK) for use as PLK cleaning validation on an automatic packaging machine. A chromatographic system comprising a YMC AM12S05-1506WT column, mobile phase of CH3CN:H2O:HClO4:NaClO4=650:350:1:5 (V/V/V/W), flow rate of 1 mL/min, and UV detector set at 254 nm was used. Candesartan cilexetil (CDC) was used as an internal standard. The PLK and CDC retention times were approximately 7.1 and 10.2 min, respectively. Regression analysis found that the method was linear over the standard curve range from 0.001 to 2.000 mg/tube. Inter-day precision and accuracy ranged between 0.40 and 19.95%, and - 5.05 and 26.31%, respectively. The precision and accuracy values were under 10% and inside a range of -10% to 10% without 0.001 mg/tube. Therefore, the lower limit of quantification was inferred to be 0.001 mg/tube. 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 for Onon® drysyrup which was a pharmaceutical preparation of PLK were101.6 ± 2.55% (mean ± SD, n=3) and 101.9 ± 0.85%, respectively.