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Drisya N. K., Clariya Rapheal*, Sreelakshmi A. R. and Dr. Prasanth S. S.


The objective of the study is to develop effective, precise and reliable analytical method for the estimation of ophthalmic drugs from selected pharmaceutical formulation and also to carry out its validation in accordance to ICH guidelines. For routine analytical purpose, it is always necessary to establish methods capable of analyzing huge number of sample in short time period with high accuracy and precision. Analytical method development includes selection of desired wavelength, solubility, linearity of various concentrations of standard drugs and formulations. The estimation of drugs in pure and in its formulations can be performed by method. In Spectrophotometric method, Methanol is used as solvent and the quantification carried out using Simultaneous equation method. The absorption maxima were found to be 248nm and 272nm for Flurbiprofen and Chloramphenicol respectively. Under the optimum reaction conditions, the linear correlation for Flurbiprofen and Chloramphenicol was found to be 0.995 and 0.997 within the concentration range 4-12 μg/ml and 10-30μg/ml respectively. Validation of this proposed method can be carried out according to ICH guidelines and applied for routine quality control analysis of Chloramphenicol and Flurbiprofen sodium in bulk and pharmaceutical formulations.

Keywords: Chloramphenicol; Flurbiprofen sodium; Vierodt’s method; Method validation; absorption maxima; ICH guidelines.

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