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ISSN (Online) : 2277-4572

DEVELOPMENT AND VALIDATION OF CLEANING PROCEDURE OF MIXING EQUIPMENT USED FOR MANUFACTURING CIPROFLOXACIN HCL AND TINIDAZOLE TABLET BY USING UV SPECTROSCOPY

Abstract

Author(s): Jansari Sneha K, Patel Nirav B*, Patel Parag, Desai Hemant T

Two simple, sensitive, rapid, accurate and economical methods were developed for the estimation of Ciprofloxacin HCl and tinidazole in two components tablet dosage form. First method is based on the simultaneous equation and second method is based on Q-analysis (absorbance ratio method). Ciprofloxacin HCl has absorbance maxima at 279.0 nm and tinidazole has absorbance maxima at 317 nm in Phosphate Buffer: Acetonitrile (80:20) solvent. The linearity was obtained in the concentration range of 1-13 μg/ml for Ciprofloxacin HCl and 1.2-15.6 µg/ml for tinidazole. In the first method, the concentrations of the drugs were determined by using simultaneous equations and in second method, the concentration of the drugs were determined by using ratio of absorbance at isoabsorptive point and at the λ-max of one of the drug. The results of analysis have been validated statistically and by recovery studies. 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 procedure validation 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 powder mixer on pharmaceutical equipment surfaces and will be useful for cleaning validation.