DEVELOPMENT OF VALIDATED STABILITY INDICATING METHOD BY RP-HPLC FOR SIMULTANEOUS ESTIMATION OF MEROPENEM AND VABORBACTAM IN BULK AND PHARMACEUTICAL FORMULATION
DOI:
https://doi.org/10.22159/ijpps.2019v11i7.33441Keywords:
Meropenem, Vaborbactam, Method development, RP-HPLCAbstract
Objective: To develop a simple, rapid, precise and reproducible liquid chromatographic method for the estimation meropenem (MEP) and vaborbactam (VAB) in bulk and pharmaceutical formulation and study of the stability of the drugs in different stressed conditions.
Methods: The chromatographic separation was achieved on a Kromasil C18 column (250 × 4.6 mm) using a mobile phase composition of acetonitrile and 10 mmol phosphate buffer (pH 3.50) in a ratio 30:70 v/v, pumped at a flow rate of 1.0 ml/min with UV detection set at 260 nm.
Results: Symmetrical and sharp peaks of MEP and VAB were obtained at retention times of 2.29 and 3.10 min, respectively. The chromatographic method was validated for linearity, limits of detection and quantitation, precision, accuracy, system suitability and robustness. Calibration curves were obtained in the concentration ranges of 25–150 μg/ml for MEP and VAB. Stability tests done through the exposure of the analytes solution for different stress conditions and the obtained results indicate no interference of degradants with HPLC method.
Conclusion: The proposed method has been found to be selective, precise, linear, accurate, and sensitive. The method can be successfully applied to the assay determination of bulk drugs and combined dosage forms for routine analysis.
Downloads
References
Patel TS, Pogue JM, Mills JP, Kaye KS. Meropenem-vaborbactam: a new weapon in the war against gram-negative bacteria. Future Microbiol 2018;13:971-83.
Centers for Disease Control and Prevention. Carbapenem-resistant Enterobacteriaceae in Healthcare Settings. Available from: https://www.cdc.gov/hai/organisms/cre/index.html [Last accessed on 01 Mar 2019]
Tacconelli E, Magrini N. Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. WHO 2017. Available from: https://www.who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ETNMWHO. pdf?ua=1 [Last accessed on 01 Mar 2019]
VABOMERE™ (Meropenem and Vaborbactam) for injection. FDA. Available from: https://www.access data.fda.gov/drugsatfda_docs/label/2017/209776lbl.pdf. [Last accessed on 01 Mar 2019]
Jorgensen SC, Rybak MJ. Meropenem and vaborbactam: stepping up the battle against carbapenem-resistant enterobacteriaceae. Pharmacotherapy 2018;38:444-61.
Hecker SJ, Reddy KR, Totrov M, Hirst GC, Lomovskaya O, Griffith DC, et al. Discovery of a cyclic boronic acid β-lactamase inhibitor (RPX7009) with utility vs class a serine carbapenemases. J Med Chem 2015;58:3682-92.
Bush K. A resurgence of β-lactamase inhibitor combinations effective against multidrug-resistant gram-negative pathogens. Int J Antimicrob Agents 2015;46:483-93.
Negi V, Chander V, Singh R, Sharma B, Singh P, Upadhaya K. Method development and validation of Meropenem in pharmaceutical dosage form by Rp-HPLC. Indian J Chem Technol 2017;24:441-6.
Casals G, Hernandez C, Hidalgo S, Morales B, Lopez Pua Y, Castro P, et al. Development and validation of a UHPLC diode array detector method for Meropenem quantification in human plasma. Clin Biochem 2014;47:223-7.
Ikawa K, Kameda K, Ikeda K, Morikawa N, Nakashima A, Ohge H, et al. HPLC method for measuring meropenem and biapenem concentrations in human peritoneal fluid and bile: application to comparative pharmacokinetic investigations. J Chromatogr Sci 2010;48:406-11.
Kloft C, Wicha SG. Simultaneous determination and stability studies of linezolid, meropenem and vancomycin in bacterial growth medium by high-performance liquid chromatography. J Chromatogr B 2016;1028:242-8.
Lobenhoffer JM, Bode-Boger SM. Quantification of meropenem in human plasma by HILIC–tandem mass spectrometry. J Chromatogr B 2017;1046:13-7.
Frenich AG, Reyes RC, Gonzalez RR, Maresca MA, Vidal JL. Simultaneous analysis of antibiotics in biological samples by ultra high performance liquid chromatography-tandem mass spectrometry. J Pharm Biomed Anal 2014;89:203-12.
Rigo Bonnin R, Ribera A, Arbiol Roca A, Cobo Sacristan S, Padulles A, Murillo O, et al. Development and validation of a measurement procedure based on ultra-high performance liquid chromatography-tandem mass spectrometry for simultaneous measurement of β-lactam antibiotic concentration in human plasma. Clin Chim Acta 2017;468:215-24.
Babu KR, Kumari NA. Spectrophotometric determination of meropenem in bulk and injection formulations by 1, 2 naphtho quinone 4-sulphonic acid (NQS) reagent. Int J Pharm Sci Res 2014;5:1963-7.
Marwada KR, Patel JB, Patel NS, Patel BD, Borkhatariya DV, Patel AJ. Ultraviolet spectrophotometry (dual wavelength and chemometric) and high performance liquid chromatography for simultaneous estimation of meropenem and salbactam sodium in pharmaceutical dosage form. Spectrochim Acta A Mol Biomol Spectrosc 2014;124:292-9.
ICH, The European Agency for the Evaluation of Medicinal Products. ICH Topic Q2B Note for Guideline on Validation of Analytical Procedures: Methodology GPMP/ICH/281/95; 1996.
ICH Guidance on Analytical Method Validation, International Convention on Quality for the Pharmaceutical Industry: Toronto, Canada; 2002.
ICH, Technical Requirements for the Registration of Pharmaceutical for Human Use; Validation of Analytical Procedures: Text and Methodology Q2 (R1); IFPMA: Geneva, Switzerland; 2005.
ICH, Q1A (R2) Stability Testing of New Drug Substances and Products. International Conference on Harmonization, Geneva; 2003.
ICH, Q1B, Stability Testing: Photostability Testing of New Drug Substances and Products, International Conference on Harmonization. IFPMA: Geneva, Switzerland; 1996.
Published
How to Cite
Issue
Section
