Abstrakt

Quantitative determination and sampling of phenylephrine hydrochloride residues for cleaning validation inmanufacturing environments

Krishnamoorthy Balamurugan, Kannan Gokulakrishnan

Cleaning validation is an integral part of current good manufacturing practices in any pharmaceutical industry. Nowadays, Phenylephrine Hydrochloride and several other pharmacologically potent pharmaceuticals are manufactured in same production area. Carefully designed cleaning validation and its evaluation can ensure that residues of Phenylephrine Hydrochloride will not carry over and cross contaminate the subsequent product. The aim of this study was to validate simple analytical method for verification of residual Phenylephrine Hydrochloride in equipments used in the production area and to confirmefficiency of cleaning procedure. The HPLC method was validated on a LCsystemusingCosmosil C18 (4.6mm×250 mm, 5µm) and methanol–water–acetic acid (30:70:1, v/v/v) as mobile phase at a flowrate of 1.0mLmin-1. UVdetectionwasmade at 257 nm. The calibration curve was linear over a concentration range from2.0 to 22.0 µgmL-1 with a correlation coefficient of 0.999. The detection limit (DL) and quantitation limit (QL) were 0.08 and 0.28 µgmL-1, respectively. The intra-day and interday precision expressed as relative standard deviation (R.S.D.) were below 2.0%. The mean recovery of method was 99.09%. The mean extractionrecovery from manufacturing equipments was 85.5%. The developed UV spectrophotometric method could only be used as limit method to qualify or reject cleaning procedure in production area. Nevertheless, the simplicity of spectrophotometric method makes it useful for routine analysis of Phenylephrine Hydrochloride residues on cleaned surface and as an alternative to proposed HPLC method.