DOI: 10.21276/sajp.2018.7.12.2

Pages: 470-473

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 nicotinamide (NA) for use as NA cleaning validation on an automatic packaging machine. A chromatographic system comprised of a YMC AM12S05-1506WT column, mobile phase CH3OH:H2O = 100:900 (V/V), flow rate 1 mL/min, and a UV detector set at 261 nm, was used. Tyrosine (TY) was used as an internal standard. The NA and TY retention times were approximately 6.8 and 4.1 min, respectively. Regression analysis found that the method was linear over the standard curve range from 0.01 to 20 mg/tube. Inter-day precision and accuracy ranged between 0.22 and 6.45%, and -4.62 and 5.84%, respectively. The precision and accuracy values were under 10%