RP-HPLC Analytical Method Development and Validation of Avibactam and Aztreonam
DOI:
https://doi.org/10.22270/ajprd.v14i01.1688Abstract
A simple, rapid, precise, sensitive, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Avibactam and Aztreonamin pharmaceutical dosage form. Chromatographic separation of Avibactam and Aztreonamwas achieved on Waters Alliance-e2695by using Luna Phenyl Hexyl (250x 4.6mm, 5µ) column and the mobile phase containing Acetonitrile: 0.1% Formic acid in the ratio of 20:80% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 250nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factors for Avibactam and Aztreonam were NLT 2000 and should not be more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Avibactam and Aztreonam study of its stability.
Downloads
References
Sai Krishna V, Anusha Y, Navya Sri Y, Anni Selviya Z, Akiful HM, Vasudha B, Narender B. Analytical method development and validation for the determination of levetiracetam in bulk and pharmaceutical formulation by RP-HPLC. International Journal of Biology, Pharmacy and Allied Sciences. 2024; 13(2):996-1008.
Konda Shravan Kumar, Duddagi Suchitra, Pavan Kumar Kasu, Sukanya Mandala, Chalavadi Sudha Bhargavi, Narender Boggula. RP-HPLC method for simultaneous estimation of trifluridine and tipiracil in pure and tablet dosage form. Biochem. Cell. Arch. 2024; 24(2):2519-24.
Sy SK, Beaudoin ME, Zhuang L, Löblein KI, Lux C, Kissel M, Tremmel R, Frank C, Strasser S, Heuberger JA, Mulder MB. In vitro pharmacokinetics/pharmacodynamics of the combination of avibactam and aztreonam against MDR organisms. Journal of Antimicrobial Chemotherapy. 2016;71(7):1866-80.
Sillén H, Mitchell R, Sleigh R, Mainwaring G, Catton K, Houghton R, Glendining K. Determination of avibactam and ceftazidime in human plasma samples by LC–MS. Bioanalysis. 2015;7(12):1423-34.
Lodise TP, Smith NM, O’Donnell N, Eakin AE, Holden PN, Boissonneault KR, Zhou J, Tao X, Bulitta JB, Fowler Jr VG, Chambers HF. Determining the optimal dosing of a novel combination regimen of ceftazidime/avibactam with aztreonam against NDM-1-producing Enterobacteriaceae using a hollow-fibre infection model. Journal of Antimicrobial Chemotherapy. 2020;75(9):2622-32.
Ye Q, Ding W, Rinaldi F, Huang Y, Miller SA,Bolgar M. Structural characterization of low level degradants in aztreonam injection and an innovative approach to aid HPLC method validation. J Pharm Biomed Anal. 2016; 124: 358-64.
Revathi Boddu, Jithendar Reddy Mandhadi, Narender Boggula, Rajeshwar Vodeti, Suchitra Duddagi. Development of Expeditious RP-HPLC Method for Simultaneous Estimation of Bilastine and Montelukast in Fixed Dosage Combination. Journal of Applied Pharmaceutical Research. 2025; 13(6):113-9.
Sandeep Bolla, Narender Boggula. Stability-indicating liquid chromatographic method for the simultaneous estimation of colchicine and rosuvastatin in combination. Essential Chem. 2025; 2(1):1-11.
Bolla, S., Boggula, N. Quantitative determination of Nebivolol Hydrochloride and Rosuvastatin Calcium in laboratory prepared mixture by robust, high-performance liquid chromatographic method. Discov. Chem. 2025; 2:61.
Duddagi Suchitra, Konda Shravan Kumar, Chalavadi Sudha Bhargavi, Racha Spandana, Puli Ramya Krishna, Narender Boggula. Determination of darunavir and cobicistat simultaneously using RP-HPLC in bulk and dosage form. Biochem. Cell. Arch. 2024; 24(2):2381-9.
Konda Shravan Kumar, Duddagi Suchitra, Pavan Kumar Kasu, Sukanya Mandala, Chalavadi Sudha Bhargavi, Narender Boggula. RP-HPLC method for simultaneous estimation of trifluridine and tipiracil in pure and tablet dosage form. Biochem. Cell. Arch. 2024; 24(2):2519-24.
Boggula N, Bhadru B, More K. RP-HPLC Method Validation for Levomilnacipran Estimation in Bulk and Formulation. International Journal of Pharmaceutical Quality Assurance. 2023; 14(4):900-3.
Narender Boggula, Dr. P. Shanmuga Pandiyan. Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Dapagliflozin and Saxagliptin in Bulk and Pharmaceutical Dosage Forms. Int J Pharm Sci & Res. 2021; 12(1):314-20.
Narasimha Kanjarla, Bhuvanachandra Pasupuleti, Narender Boggula, Praveen K Kusuma, Daniel Kothapally, Vamshikrishna Gone, Gangarapu Kiran. A HPLC-MS/MS method for the determination of Nadolol in rat plasma: Development, validation, and application to pharmacokinetic study. European Journal of Mass Spectrometry. 2023; 29(3):170-80.
Abdul Rasheed, Ramachandran D and Jameelunnisa Begum, Spectrophotometric determination of Aztreonam in Bulk and its Pharmaceutical Formulations. Asian Journal of Chemistry. 2010; 22(4): 2491-4.
Thaidala Sriveni, Vanamala Naveen, Vemula Sai Rupa, Aeruva Renuka, Sunil Porika, M Akiful Haque, Vasudha Bakshi, Narender Boggula. Development and Validation of Dolutegravir in Bulk and Formulation: An Anti-Retroviral Drug Using UV-Spectroscopy. International Journal of Pharmaceutical Quality Assurance. 2021; 12(1):57-60.
Akula Sushma,Konda Shravan Kumar, Narender Boggula, Duddagi Suchitra. RP-HPLC Method Development and Validation of Lopinavir and Ritonavir in Bulk and Pharmaceutical Dosage Forms. Advances in Bioresearch. 2024; 15(5):280-9.
Gouthami Thumma, Narender Boggula, Vasudha B, Anand Kumar Chettupalli. Method Development and Validation for the Simultaneous Analysis of Duloxetine HCL and Methylcobalamine by RP-HPLC. International Journal of Pharmaceutical Quality Assurance. 2018; 9:363-7.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2026 Gangu Sreelatha, Nandini Kolli, Arunabha Mallik
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
. 