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

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.

[1]  Mukesh Kumar,et al.  Simultaneous determination of amphotericin B, tobramycin and vancomycin in rabbit ocular biofluids and tissues by LC-MS/MS: An antimicrobial therapy for keratitis and its PK-PD application. , 2023, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[2]  Mukesh Kumar,et al.  Concurrent determination of anti-microbial and anti-inflammatory drugs in lachrymal fluid and tissue by LC-MS/MS: A potential treatment for microbial keratitis and its PK-PD evaluation. , 2023, Journal of pharmaceutical and biomedical analysis.

[3]  P. Mishra,et al.  Dacarbazine-primed carbon quantum dots coated with breast cancer cell-derived exosomes for improved breast cancer therapy. , 2023, Journal of controlled release : official journal of the Controlled Release Society.

[4]  R. Bhatta,et al.  Trends in Formulation Approaches for Sustained Drug Delivery to the Posterior Segment of the Eye , 2023, AAPS PharmSciTech.

[5]  Mukesh Kumar,et al.  Recent Insights into the Etiopathogenesis of Diabetic Retinopathy and Its Management. , 2023, Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics.

[6]  Sanjeev Kanojiya,et al.  Hesperidin: Enrichment, forced degradation, and structural elucidation of potential degradation products using spectral techniques. , 2023, Rapid communications in mass spectrometry : RCM.

[7]  Baoqin Lin,et al.  Pharmacokinetics of Sirolimus Eye Drops Following Topical Ocular Administration in Rabbits. , 2023, Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics.

[8]  R. Bhatta,et al.  Ophthalmic nano-bioconjugates: critical challenges and technological advances. , 2023, Therapeutic delivery.

[9]  R. Bhatta,et al.  COVID‐19 retreats and world recovers: A silver lining in the dark cloud , 2023, Health care science.

[10]  S. Gupta,et al.  UHPLC Method for Quantification of Bioactive Components in Fenugreek Herbal Preparations , 2023, Revista Brasileira de Farmacognosia.

[11]  R. Bhatta,et al.  Recent update on pharmacokinetics and drug metabolism in CNS-based drug discovery. , 2023, Current pharmaceutical design.

[12]  Arpon Biswas,et al.  Chemical metabolite synthesis and profiling: Mimicking in vivo biotransformation reactions. , 2023, Bioorganic chemistry.

[13]  T. Narender,et al.  Preclinical pharmacokinetics of 4-hydroxy isoleucine using LC-MS/MS: a potential polycystic ovary syndrome phytopharmaceutical therapeutics. , 2023, Bioanalysis.

[14]  Mukesh Kumar,et al.  A QbD-led Simple and Sensitive RP-UHPLC method for Simultaneous Determination of Moxifloxacin, Voriconazole, and Pirfenidone: An Application to Pharmaceutical Analysis. , 2023, Biomedical chromatography : BMC.

[15]  Mukesh Kumar,et al.  LC-MS/MS based quantification of steroidal biomarkers in polycystic ovary syndrome induced rats. , 2023, Journal of pharmaceutical and biomedical analysis.

[16]  Jinsong Ding,et al.  Topical Delivery of Ketorolac Tromethamine via Cataplasm for Inflammatory Pain Therapy , 2023, Pharmaceutics.

[17]  Ashok Kumar,et al.  Simultaneous pharmacokinetic assessment of phytopharmaceuticals from Fenugreek extract by liquid chromatography-tandem mass spectrometry in Sprague Dawley rats. , 2023, Biomedical chromatography : BMC.

[18]  R. Bhatta,et al.  Liquid chromatography‐tandem mass spectrometry method for simultaneous assessment of ofloxacin and dexamethasone in ocular biofluids: Application to ocular pharmacokinetic studies , 2022, SEPARATION SCIENCE PLUS.

[19]  Hongqun Qiao,et al.  Simultaneous Determination of Moxifloxacin Hydrochloride and Dexamethasone Sodium Phosphate in Rabbit Ocular Tissues and Plasma by LC-MS/MS: Application for Pharmacokinetics Studies , 2022, Molecules.

[20]  S. Chopra,et al.  Chitosan/HPMC-based mucoadhesive film co-loaded with fluconazole and ofloxacin for management of polymicrobial keratitis. , 2022, International journal of biological macromolecules.

[21]  R. Bhatta,et al.  A recent update on therapeutic potential of vesicular system against fungal keratitis , 2022, Journal of Drug Delivery Science and Technology.

[22]  S. Chopra,et al.  QbD based antifungal drug-loaded ophthalmic liposomal formulation for the management of fungal keratitis: In vitro, ex vivo and in vivo pharmacokinetic studies , 2022, Journal of Drug Delivery Science and Technology.

[23]  R. Bhatta,et al.  A Qbd Driven Approach for Development and Validation of an RP-UHPLC Method for Simultaneous Estimation of Ofloxacin and Fluconazole: An Application to Pharmaceutical Analysis , 2022, Analytical Chemistry Letters.

[24]  A. Urtti,et al.  Understanding dexamethasone kinetics in the rabbit tear fluid: drug release and clearance from solution, suspension and hydrogel formulations. , 2022, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[25]  A. Ebrahimi,et al.  Contact Lens Associated Bacterial Keratitis: Common Organisms, Antibiotic Therapy, and Global Resistance Trends: A Systematic Review , 2021, Frontiers in Ophthalmology.

[26]  R. Bhatta,et al.  Simultaneous determination of fluconazole and ofloxacin in rabbit tear fluid by LC-MS/MS: Application to ocular pharmacokinetic studies. , 2021, Journal of pharmaceutical and biomedical analysis.

[27]  S. Tulsankar,et al.  Rapid and Simultaneous Analysis of Multiple Classes of Antimicrobial Drugs by Liquid Chromatography-Tandem Mass Spectrometry and Its Application to Routine Biomedical, Food, and Soil Analyses , 2020, ACS omega.

[28]  P. Shukla,et al.  Topical corneal targeted sustained release amphotericin B liposomal formulation for the treatment of fungal keratitis and its PK-PD evaluation , 2020 .

[29]  İ. Köksal,et al.  Determination of levofloxacin, ciprofloxacin, moxifloxacin and gemifloxacin in urine and plasma by HPLC-FLD-DAD using pentafluorophenyl core-shell column: Application to drug monitoring. , 2020, Biomedical chromatography : BMC.

[30]  H. Uusitalo,et al.  Comparison of Capillary and Schirmer Strip Tear Fluid Sampling Methods Using SWATH-MS Proteomics Approach , 2020, Translational vision science & technology.

[31]  D. Touw,et al.  Therapeutic drug monitoring using saliva as matrix: an opportunity for linezolid, but challenge for moxifloxacin , 2020, European Respiratory Journal.

[32]  M. Gilmore,et al.  The persistent dilemma of microbial keratitis: Global burden, diagnosis, and antimicrobial resistance. , 2019, Survey of ophthalmology.

[33]  K. Heinig,et al.  Ocular bioanalysis: challenges and advancements in recent years for these rare matrices. , 2017, Bioanalysis.

[34]  M. Medenica,et al.  Determination of olopatadine in human tears by hydrophilic interaction liquid chromatography-MS/MS method. , 2017, Bioanalysis.

[35]  L. J. Chen,et al.  Infectious keratitis and orthokeratology lens use: a systematic review , 2017, Infection.

[36]  A. Czyrski,et al.  HPLC method for determination of moxifloxacin in plasma and its application in pharmacokinetic analysis , 2017 .

[37]  R. Urman,et al.  Ketorolac Tromethamine – Routes and Clinical Implications , 2015, Pain practice : the official journal of World Institute of Pain.

[38]  Abdelwahab Omri,et al.  Preparation and evaluation of nanoparticles loaded ophthalmic in situ gel , 2015, Drug delivery.

[39]  G. Cameron,et al.  Development of an enantiomer selective microsampling assay for the quantification of ketorolac suitable for paediatric pharmacokinetic studies , 2013, Biopharmaceutics & drug disposition.

[40]  O. Jonsson,et al.  Capillary microsampling in the regulatory environment: validation and use of bioanalytical capillary microsampling methods. , 2013, Bioanalysis.

[41]  B. Alquadeib,et al.  Pharmacokinetics of ketorolac loaded to polyethylcyanoacrylate nanoparticles using UPLC MS/MS for its determination in rats. , 2010, International journal of pharmaceutics.

[42]  B. Greijdanus,et al.  Determination of moxifloxacin in human plasma, plasma ultrafiltrate, and cerebrospinal fluid by a rapid and simple liquid chromatography- tandem mass spectrometry method. , 2010, Journal of analytical toxicology.

[43]  A. Mitra,et al.  Ocular microdialysis: a continuous sampling technique to study pharmacokinetics and pharmacodynamics in the eye. , 2010, Bioanalysis.

[44]  Marilyn J. Schneider Methods for the analysis of fluoroquinolones in biological fluids. , 2009, Bioanalysis.

[45]  H. Taylor,et al.  Clinical efficacy of moxifloxacin in the treatment of bacterial keratitis: a randomized clinical trial. , 2007, Ophthalmology.

[46]  B. Matuszewski,et al.  Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS. , 2003, Analytical chemistry.

[47]  J. Balfour,et al.  Moxifloxacin , 2012, Drugs.

[48]  A. Khuroo,et al.  A Validated High-Performance Liquid Chromatography-Tandem Mass Spectrometric (Lc-Ms/Ms) Method for Simultaneous Determination of R( , 2011 .