Simultaneous estimation of voriconazole, moxifloxacin, and pirfenidone in rabbit lacrimal matrix using LC-MS/MS: an application to preclinical ocular pharmacokinetics

Bisen, Amol Chhatrapati; Agrawal, Sristi; Sanap, Sachin Nashik; Mishra, Anjali; Biswas, Arpon; Verma, Sagar; Bhatta, Rabi Sankar

doi:10.1039/d3ay00317e

Cited by 19 publications

(11 citation statements)

References 38 publications

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“…[49] Therefore, to combat such clinical condition called as ulcerative keratitis there is need of antibacterial/antifungal agent to kill the pathogens. [50,51] A similar study building upon this foundation was conducted by Tawfik et al In their work, they developed co-axial nanofibers loaded with dual drugs (pirfenidone and moxifloxacin) for addressing corneal abrasions. This experimentation was carried out using a rabbit model.…”

Section: Markersmentioning

confidence: 93%

“…[98,99] Following post-operative surgery, trauma, and various ophthalmic procedures, the occurrence of bacterial and fungal co-infections can lead to the development of ulcers on the cornea. [51,100] These ulcers can result in scarring, ultimately causing vision impairment. If left untreated, the infection can potentially spread to the brain, posing a serious risk to the patient's life.…”

Section: Ulcerative Microbial Keratitismentioning

confidence: 99%

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Pirfenidone: A Promising Drug in Ocular Therapeutics

Bisen,

Agrawal,

Rayiti

et al. 2024

Chemistry & Biodiversity

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Pirfenidone, initially indicated for lung fibrosis, has gone beyond its original purpose, and shown promise in eye care. This detailed review tracks its evolution from lung treatment to aiding eye healing as evidenced by published literature. Pirfenidone's multifaceted attributes extend to mitigating corneal fibrosis, inflammation, and trauma. Through rigorous investigations, its efficacy emerges in diabetic retinopathy, macular degeneration, and postoperative glaucoma interventions. As an unheralded protagonist, pirfenidone reshapes ocular care paradigms, inviting renewed research opportunities.

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Section: Markersmentioning

confidence: 93%

Section: Ulcerative Microbial Keratitismentioning

confidence: 99%

Pirfenidone: A Promising Drug in Ocular Therapeutics

Bisen,

Agrawal,

Rayiti

et al. 2024

Chemistry & Biodiversity

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“…High‐purity N 2 was used as the nebulizing gas at a flow rate of 50 L/h and drying gas at a flow rate of 650 L/h. Argon was used as the collision gas 37–39 …”

Section: Methodsmentioning

confidence: 99%

Hesperidin: Enrichment, forced degradation, and structural elucidation of potential degradation products using spectral techniques

Bisen,

Rawat,

Sharma

et al. 2023

Rapid Comm Mass Spectrometry

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RationaleHesperidin (HES) is a well‐known citrus bioflavonoid phyto‐nutraceutical agent with polypharmacological properties. After 2019, HES was widely used for prophylaxis and COVID‐19 treatment. Moreover, it is commonly prescribed for treating varicose veins and other diseases in routine clinical practice. Pharmaceutical impurities and degradation products (DP) impact the drug's quality and safety and thus its effectiveness. Therefore, forced degradation studies help study drug stability, degradation mechanisms, and their DPs. This study was performed because stress stability studies using detailed structural characterization of hesperidin are currently unavailable in the literature.MethodsIn the HES enrichment method crude HES was converted to its pure form (98% purity) using column chromatography and then subjected to forced degradation under acid, base, and neutral hydrolyses followed by oxidative, reductive, photolytic, and thermal stress testing (International Conference on Harmonization guidelines). The stability‐indicating analytical method (SIAM) was developed to determine DPs using reversed‐phase high‐performance liquid chromatography (C18 column with methanol and 0.1% v/v acetic acid in deionized water [70:30, v/v] at 284 nm). Further, structural characterization of DPs was performed using liquid chromatography‐electrospray ionization‐tandem mass spectrometry (LC‐ESI‐MS/MS) and nuclear magnetic resonance (NMR) spectroscopy. In addition, in silico toxicity predictions were performed using pKCSM and DataWarior freeware.ResultsHES was found to be susceptible to acidic and basic hydrolytic conditions and yielded three DPs in each, which were detected using designed SIAM. Of six DPs, three were pseudo‐DPs (short lived), and the remaining were characterized using LC–MS/MS and NMR spectroscopy. The tentative mechanism of the formation of proposed DPs was explained. The proposed DPs were found inactive from in silico toxicity predictions.ConclusionsHesperidin was labile under acidic and basic stress conditions. The potential DPs were characterized using LC‐ESI‐MS/MS and NMR spectral techniques. The proposed mechanism of formation was hypothesized. In addition, to identify and characterize the DPs, a SIAM, which has broad biomedical applications, was successfully developed.

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“…The literature revealed its promising activity to heal corneal ulcers by downregulating the release of matrix metalloproteinase enzymes, thus accelerating wound healing and retaining eyesight without corneal astigmatism (Friedlander, 2007;Khanum et al, 2017;Mohan et al, 2014). (Bisen et al, 2023; Figure 1). Most articles report the method development of individual analytes or in combination with analogous drugs within the same family.…”

Section: Introductionmentioning

confidence: 99%

“…At present, no reverse phase ultrahigh performance liquid chromatography (RP‐UHPLC) technique is available in the literature for the simultaneous determination of MFX, VCZ and PIR in pharmaceutical dosage forms or bulk, according to the experimental design method. Very little documented work is available in the literature based on the determination of MFX, VCZ and PIR (Bisen et al, 2023; Figure 1). Most articles report the method development of individual analytes or in combination with analogous drugs within the same family.…”

Section: Introductionmentioning

confidence: 99%

A QbD‐led simple and sensitive RP‐UHPLC method for simultaneous determination of moxifloxacin, voriconazole, and pirfenidone: An application to pharmaceutical analysis

Bisen

Sanap

Biswas

et al. 2023

Biomedical Chromatography

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A novel, quick and precise RP‐UHPLC analytical method for the simultaneous determination of moxifloxacin (MFX), voriconazole (VCZ) and pirfenidone (PIR) was developed and validated according to the International Conference on Harmonization guidelines using a QbD‐driven response surface Box–Behnken design. The developed method was validated considering the selectivity, sensitivity, linearity, accuracy‐precision, robustness, stability, limit of detection and limit of quantification, respectively. Resolution between MFX, VCZ and PIR was achieved using a gradient elution protocol against a Waters Symmetry Shield C18 column (150 × 4.6 mm2, 5 μm) using an Agilent 1290, Infinity II series LC system. The method was applied to quantitatively estimate proprietary and in‐house prepared pharmaceutical topical ophthalmic formulations containing MFX, VCZ and PIR at wavelength (λmax) of 296, 260 and 316 nm. The method is sensitive enough to detect up to 0.1 ppm of analytes in the formulation. The method was further exploited to study and identify the possible degradation products of the analytes. The proposed chromatographic method is simple, economical, reliable and reproducible. In conclusion, the developed method could be applicable for routine quality control analysis of single or combined MFX, VCZ and PIR‐containing units or bulk dosage forms in pharmaceutical industries and research organizations working on drug discovery and development.

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Simultaneous estimation of voriconazole, moxifloxacin, and pirfenidone in rabbit lacrimal matrix using LC-MS/MS: an application to preclinical ocular pharmacokinetics

Abstract: Simultaneous preclinical pharmacokinetics of VCZ, MOXI, and PIR using LC-MS/MS.

Cited by 19 publications

References 38 publications

Pirfenidone: A Promising Drug in Ocular Therapeutics

Pirfenidone: A Promising Drug in Ocular Therapeutics

Hesperidin: Enrichment, forced degradation, and structural elucidation of potential degradation products using spectral techniques

A QbD‐led simple and sensitive RP‐UHPLC method for simultaneous determination of moxifloxacin, voriconazole, and pirfenidone: An application to pharmaceutical analysis

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