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World Journal of Pharmacy and
Pharmaceutical Sciences

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Medical Research and Technology

Impact Factor : 8.485

ICV : 84.65

WJPPS Citation

	All	Since 2020
Citation	6651	4087
h-index	26	21
i10-index	174	83

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Abstract

SYNTHESIS CHARACTERIZATION AND QUANTIFICATION OF PROCESS RELATED QUINOLONE IMPURITY IN BULK AND FORMULATION OF BALOFLOXACIN

Shekhar R. Inamke*, V. S. Kasture, S. D. Musmade, R. K. Ajage, S. G. Deshpande

ABSTRACT

The present research work deals with the synthesis, characterization and quantitation of process related impurity of balofloxacin. The impurity was synthesized by retro synthesis technique using Skraup synthesis method. The synthesized impurity was characterized by modern method of analysis such as UV, FT-IR, NMR, GC-MS. For the quantitative analysis RP-HPLC method was developed and validated as per ICH guidelines. The RP-HPLC method was found to be linear, precise, rugged, robust and accurate. The amount of impurity present in the bulk and formulation was found to be within the official limit.

Keywords: Impurity, Balofloxacin, RP-HPLC.

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