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RESEARCH JOURNAL OF PHARMACY AND TECHNOLOGY
Year : 2021, Volume : 14, Issue : 1
First page : ( 363) Last page : ( 368)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2021.00066.4

UHPLC method development, validation and forced degradation study for simultaneous estimation of vaborbactam and meropenem in bulk drug

Kuber B. Ramya1*, Geethika B.2

1Department of Pharmacognosy, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam, Tirupati (Women's University), Tirupati, Andhra Pradesh.

2Department of Pharmaceutical analysis, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam, Tirupati (Women's University), Tirupati, Andhra Pradesh.

*Corresponding Author E-mail: brkuber01@gmail.com

Online published on 22 April, 2021.

Abstract

The accurate, precise, sensitive and economical spectrophotometric method was developed, validated and force degraded studies for simultaneous estimation of Meropenem and Vaborbactam in bulk drug. The UV method employed was simultaneous equation method. Chromatographic conditions involved in UHPLC C18 column with the mobile phase consisting of methanol and water. The method employs 261nm as λ1 and 273nm as λ2 for formation of equations. Vaborbactam and Meropenem obeys vandeemter equation in the concentration range 20–50μg/mL−1 (0.999) and 20–50μg/mL−1 (0.999). The calibration graph were plotted linear. The mean recovery for vaborbactam and meropenem was found to be 99.6% and 99.4% respectively. The limit of detection and quantification are determined and were found to be 0.025μg/ml and 0.045μg/ml. The developed method were validated according to ICH guidelines and values of accuracy, precision, LOD and LOQ, robustness and ruggedness. were found to be in good accordance with the prescribed values. Upon validation, the developed method effectively detected the drug as a pure compound. The drug was subjected to stress condition of peroxide, photolytic, acid, alkaline and thermal degradation, considerable degradation was found in thermal degradation studies. Thus the proposed methods were successfully applied for simultaneous determination of vaborbactam and meropenem in routine industry work.

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Keywords

UHPLC, Vaborbactam, Meropenem, System suitability, Precision, And Degradation studies.

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