Research Article

Ocular bioanalysis of moxifloxacin and ketorolac tromethamine in rabbit lacrimal matrix using liquid chromatography–tandem mass spectrometry

https://orcid.org/0000-0003-4841-0140

Pharmaceutics & Pharmacokinetics Division, CSIR-Central Drug Research Institute, Lucknow, 226031, India

Academy of Scientific & Innovative Research (AcSIR), CSIR-HRDC Campus, Ghaziabad, Uttar Pradesh, 201002, India

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Rabi Sankar Bhatta

*Author for correspondence: Tel.: +91 522 277 2974; Ext.: 4853;

E-mail Address: rabi_bhatta@cdri.res.in

https://orcid.org/0000-0003-4844-2388

Pharmaceutics & Pharmacokinetics Division, CSIR-Central Drug Research Institute, Lucknow, 226031, India

Academy of Scientific & Innovative Research (AcSIR), CSIR-HRDC Campus, Ghaziabad, Uttar Pradesh, 201002, India

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Published Online:10 Jan 2024https://doi.org/10.4155/bio-2023-0233

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Abstract

Aim: The fixed-dose combination of moxifloxacin (MOXI) and ketorolac tromethamine (KTR) is widely used for the treatment of bacterial keratitis. Thus, a new LC–MS/MS method was developed to determine MOXI and KTR in lacrimal fluid. Methods: Bioanalysis was performed using a Shimadzu 8050 LC–MS/MS in electrospray ionization-positive mode and the method was validated per US FDA guidelines. Isocratic separation was performed with a Waters Symmetry C₁₈ column using methanol and 0.1% formic acid containing deionized water (85:15, v/v). Results & conclusion: An easy, quick and selective method was established and applied to assess the ocular pharmacokinetic profile of a commercially available formulation containing MOXI and KTR. Based on the pharmacokinetic data, this work describes pharmacokinetics-based dosage regimen calculations and their clinical significance.

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Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 16, No. 4

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History

Received 6 November 2023

Accepted 14 December 2023

Published online 10 January 2024

Published in print February 2024

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Acknowledgments

AC Bisen is thankful to the Indian Council of Medical Research, New Delhi, India, for providing senior research fellowship grant. The authors express their gratitude to Ms Sristi Agrawal (ICMR-SRF) for her valuable assistance throughout the project. The authors extend further thanks to the research trainees Mr Ayush Dubey and Mr Saurabh Srivastava for their kind assistance. The CSIR-CDRI communication no. is 10716.

Financial disclosure

The authors have no financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, stock ownership or options and expert testimony.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.

Animal ethics statement

Animal experimentation was conducted with the necessary approval from the Institutional Animal Ethics Committee of CSIR-Central Drug Research Institute, Lucknow, India (reference no. IAEC/2021/71/Renew-1/Sl.No.05/Dated-02.06.2023).

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