Development and validation of HPLC and GCMS method for the determination of metronidazole residues on manufacturing equipment surfaces

Shilpa Sudhakar Harak*, Sarita Suryabhan Pawar, Prasad Laxman Gorde

GES Sir Dr M S Gosavi College of Pharmaceutical Education and Research, Nashik, Maharashtra, India

ABSTRACT

Cleaning of manufacturing equipment and area including removal of drug residues is an essential step in the pharmaceutical industry. For this purpose, validated cleaning procedures are required. Also, methods to determine trace amounts of drugs are also an integral part of this procedure. We have developed HPLC and GCMS methods for the determination of metronidazole in lab equipment. The metronidazole residue swab samples were analyzed and validated to optimize the cleaning procedure. For sampling of the metronidazole residue, the swabbing procedure was optimized such that a suitable recovery of metronidazole was obtained from stainless steel. A mean recovery above 90% was obtained for both HPLC and GCMS, when swabs moistened with methanol–water (1:1, v/v) mixture were used.

Keywords:

Residual analysis, Metronidazole, swabbing recovery, HPLC, GCMS.