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

Sanapala Aarun Kumar

Abstract


A validated Rp-hplc method was developed for simultaneous estimation of ceftolozane & 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 ceftolozane 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 & LOQ. The % assay of Ceftolozane & Tazobactum was found to be 101.3% & 101.8%. The linearity shown by the drugs at a concentration range of 50-150ppm of ceftolozane & 25-75ppm of tazobactum showing regression co-efficient of 0.999 respectively. The LOD of ceftolozane & tazobactum was found to be 1.46 & 4.45 and LOQ was found to be 0.47 & 1.42 respectively. The current newly developed method was validated as per the ICH guidelines.


Keywords


RP-Hplc, Quantification, Zerbaxa injection, Acetonitrile, Phosphate buffer pH 4, Ceftalazone and Tazobactum.

References


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Shabana Sulthana MD1, Anuradha V2, Mandava V Basaveswara Rao3*, Determination of Ceftalazone and Tazobactum in Bulk and Pharmaceutical Dosage Forms by RP-HPLC. Der Pharma Chemica, 2017, 9(12):157-162.




URN: https://pmindexing.com/index.php/IJCPA/issue/view/urn:pmi:jr:0011ijcpa.v5i4.14741

DOI: https://pmindexing.com/91.1211/ijcpa.v5i4.1474

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