VALIDATION OF CLEANING PROCEDURE FOR ELIMINATION OF OFLOXACIN AND METRONIDAZOLE BENZOATE FROM MIXING EQUIPMENT BY USING UV SPECTROSCOPYAbstract
This research manuscript describes simple, sensitive, accurate, precise and repeatable UV spectroscopic method for the simultaneous determination of Metronidazole (MET) and Ofloxacin (OFL) in suspension dosage form). Metronidazole has absorbance maxima at 318.0 nm and Ofloxacin has absorbance maxima at 294 nm in Methanol and Water (50:50) solvent. The linearity was obtained in the concentration range of 1-13 μg/ml for Metronidazole and 1-13 µg/ml for Ofloxacin with mean accuracies 99.73 ± 0.05 and 99.13 ± 0.41 for Metronidazole and Ofloxacin, respectively. This paper presents a useful UV spectroscopic method for validating equipment cleaning procedures and verifying cleaning in a pharmaceutical plant. The study summarizes the initial steps that should be taken into account and focuses particularly on the solutions to some of the most critical considerations (e.g., detection and quantification limits, recovery). Cleaning validation is the process of assuring that cleaning procedures effectively remove the residue from manufacturing equipment/facilities below a predetermined level. This is necessary to assure the quality of future products using the equipment, to prevent cross-contamination, and as a World Health Organization Good Manufacturing Practices requirement. In this article we discuss the UV method that we developed for measuring residual of Ofloxacin and Metronidazole benzoate suspension contain ofloxacin (50mg/5ml) and metronidazole benzoate equivalent to metronidazole (100mg/5ml) on surface of mixing tank during manufacturing process. The method with correlation coefficient R² = 0.999 and method offers low detection capability and rapid sample analysis time. The accurate recovery values with method precision less than 2%RSD of precision, UV method is applicable for determining residual of suspension on pharmaceutical equipment surfaces and will be useful for cleaning validation.
Nirav B. Patel*, Sneha K. Jansari , Alpesh C. Arvadiya and Hemant T. Desai
QC Chemist, Nirlife Healthcare (Healthcare Division of Nirma), Sachana (382150), Ahemdabad, Gujrat, India
27 March, 2012
23 April, 2012
16 June, 2012
01 July 2012