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Pharmaceutics
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RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF CEFTALAZONE AND TAZOBACTUM IN BULK AND IN ITS PHARMACEUTICAL DOSAGE FORMS


Abstract

Author(s): Kandala Neela Maneesha*, Namratha Sunkara, Sanapala Arun Kumar, P. Rama Lakshmi

A validated RP-HPLC method was developed for simultaneous estimation of Ceftalazone and Tazobactam in bulk and in its
pharmaceutical dosage form. The current method is simple, precise, and accurate and can be used for the quantification in the
regular quality control tests and in industries. The optimization of the method was done by using several combinations of mobile
phases and different columns and finally the chromatograms showed good resolution, retention time, peak response and lowest
noise base line ratio by using Acetonitrile and phosphate buffer of pH 4 at a ratio of 70:30%v/v at a wavelength of 234nm using UV
detector for detection. The retention time of Ceftalazone and Tazobactum was found to be 2.42 & 4.42 at a flow rate of 1ml/min.
The current method was validated for accuracy, % assay, precision, Linearity, LOD and LOQ. The % assay of Ceftalazone and
Tazobactum was found to be 101.3% and 101.8%. The linearity shown by the drugs at a concentration range of 50-150ppm of
Ceftalazone and 25-75 ppm of Tazobactum showing regression co-efficient of 0.999, respectively. The LOD of Ceftalazone &
Tazobactum was found to be 1.46 and 4.45 and LOQ was found to be 0.47 and 1.42, respectively. The current newly developed
method was validated as per the ICH guidelines.

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