PATENT-INTEGRATED REVIEW ON BIOANALYTICAL METHODS FOR RECENT ANTIVIRAL AND ANTIBACTERIAL DRUGS

PATENT-INTEGRATED REVIEW ON BIOANALYTICAL METHODS FOR RECENT ANTIVIRAL AND ANTIBACTERIAL DRUGS

Niloufer Tasnim Khazi * and Kumaraswamy Gandla

Department of Pharmaceutical Analysis, Chaitanya Deemed to be University, Gandipet, Hyderabad, Telangana, India.

ABSTRACT: This review article delivers an in-depth examination of the bioanalytical methodologies and associated patented innovations for antiviral and antibacterial drugs from 2015 to 2025. The rapid global spread of infectious diseases, including COVID-19 and drug-resistant bacterial infections, has necessitated accelerated pharmaceutical advancements supported by robust analytical frameworks. The paper focuses on the critical role of HPLC and LC-MS/MS in drug quantification, pharmacokinetic profiling, and method validation aligned with regulatory guidelines such as ICH M10, FDA, and EMA. Incorporating over 75 references and numerous patents, the article highlights patented innovations in liposomal formulations, nanoparticle delivery systems, pediatric and mucosal dosage forms, and stability-enhanced oral/sublingual variants for drugs like Favipiravir, Remdesivir, Linezolid, Vancomycin, and Molnupiravir. Analytical strategies for matrix effect mitigation, microsampling techniques, AI-driven workflows, and challenges in harmonizing global validation standards are critically assessed. Future directions emphasize digital integration, pediatric drug development, and open-access repositories for analytical protocols and patent databases. This comprehensive perspective serves as a valuable resource for pharmaceutical scientists, regulatory authorities, and industry innovators in developing effective and regulatory-compliant therapeutic solutions. This comprehensive review provides an integrated evaluation of recent patents and analytical strategies in the development and validation of bioanalytical methods for antiviral and antibacterial drugs. Emphasis is placed on LC-MS/MS and HPLC methodologies that meet regulatory standards. An extensive survey of recent patents (2015–2025) supports the evolving landscape of drug delivery innovations and analytical challenges. This work aims to guide future pharmaceutical analysis with a focus on research gaps, matrix effects, and regulatory harmonization under ICH M10.

Keywords: Antiviral, Antibacterial, HPLC, LC-MS/MS, Bioanalytical Method Validation, Patents, Regulatory Guidelines, Drug Formulations

INTRODUCTION: The emergence of viral pandemics and antibiotic-resistant bacteria has amplified the global need for effective antiviral and antibacterial therapies.

Accurate and validated bioanalytical methods are essential for the quantification, monitoring, and regulatory approval of these drugs.

Among them, High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS) remain the cornerstone technologies. These methodologies help evaluate pharmacokinetics, stability, dosage form performance, and therapeutic drug monitoring.

This article integrates analytical strategies and recent patents to support innovations in pharmaceutical sciences, with a particular focus on antiviral and antibacterial agents.

FIG. 1: GRAPHICAL ABSTRACT: PATENT-INTEGRATED BIOANALYTICAL WORKFLOW (2015-2025)

Classification and Mechanism of Action of Antiviral and Antibacterial Drugs: Antibacterial agents are categorized based on their biochemical targets and mechanism of action, enabling focused therapy and resistance management. Similarly, antiviral agents target specific viral replication mechanisms. Table 1 and 2 summarize the key drug classes, representative drugs, and their mechanisms.

TABLE 1: CLASSIFICATION OF ANTIBACTERIAL DRUGS BY MECHANISM OF ACTION

TABLE 2: CLASSIFICATION OF ANTIVIRAL DRUGS BY MECHANISM OF ACTION

Chemical Structures of New Anti-Bacterial and Anti-Viral Drugs:

  FIG. 2: REPRESENTATIVE STRUCTURES OF REMDESIVIR AND LINEZOLID (ILLUSTRATIVE ONLY)

Analytical Techniques in Bioanalysis: In pharmaceutical analysis, the choice of analytical technique is dictated by the drug’s chemical nature, formulation type, and matrix complexity. Antiviral and antibacterial drugs often require highly sensitive and selective methods due to their low plasma concentrations and potential for matrix interferences. Below are key bioanalytical techniques employed:

High-Performance Liquid Chromatography (HPLC): HPLC remains the most widely used analytical tool (Lee & Kim, 2021) ⁵⁸ in pharmaceutical quality control and method validation. It provides robust separation and quantification for compounds with UV absorbance. Antibacterials like Linezolid and Doxycycline are often analyzed using HPLC due to their strong UV signatures. Key benefits include precision, repeatability, and versatility in mobile phase selection.

FIG. 3: HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)

Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS): LC-MS/MS is the gold standard for detecting and quantifying ^{60, 69} trace levels of drugs in biological matrices. It combines high chromatographic resolution with mass-specific detection, making it ideal for complex antivirals like Remdesivir, Molnupiravir, and Nirmatrelvir. Validation typically covers selectivity, sensitivity, recovery, matrix effects, and carryover per ICH M10 and FDA guidelines.

FIG. 4: LIQUID CHROMATOGRAPHY–TANDEM MASS SPECTROMETRY (LC-MS/MS)

Ultra-Performance Liquid Chromatography (UPLC): UPLC offers higher resolution and faster run times compared to conventional HPLC. It is well-suited for high-throughput labs involved in pharmacokinetic studies. This technique is increasingly applied to combination drug analysis and stability indicating methods.

UV-Visible Spectrophotometry: Although not as selective as chromatographic techniques, UV-Vis spectrophotometry is used for in-process control, especially during manufacturing. It is applicable to antibiotics like Doxycycline and some antivirals in bulk or simple formulations.

FIG. 5: UV-VISIBLE SPECTROPHOTOMETRY

Review of Patents for Antiviral and Antibacterial Drugs (2015–2025): Recent years have seen a surge in patents focused on novel drug formulations ^{72, 79}, stability enhancement, and targeted delivery systems. These innovations often integrate with bioanalytical method development to ensure quantification and quality control. Below is a categorized review of recent patents related to antibacterial and antiviral drugs.

TABLE 3: NOTABLE PATENTS FOR ANTIBACTERIAL DRUGS (2015–2025)

TABLE 4: NOTABLE PATENTS FOR ANTIVIRAL DRUGS (2015–2025)

TABLE 5: NOTABLE PATENTS FOR ANTIBACTERIAL AND ANTIVIRAL DRUGS (2015–2025)

Regulatory Frameworks for Bioanalytical Method Validation: The reliability of bioanalytical data hinges on rigorous validation ⁷⁴ aligned with regulatory standards. The International Council for Harmonisation (ICH) and U.S. Food and Drug Administration (FDA) offer globally recognized guidelines:

ICH Q2(R1): Defines parameters including specificity, linearity, accuracy, precision, detection limit (LOD), quantitation limit (LOQ), and robustness. Widely used in early method development.

FDA 2018 Guidance: Focuses on full method validation, including matrix effect evaluation, stability studies, carryover, reinjection reproducibility, and incurred sample reanalysis. It applies to both preclinical and clinical bioanalysis.

ICH M10 Draft (2022): Introduces harmonized requirements for chromatographic and ligand-binding assays. It consolidates guidance for sample handling, reanalysis, validation, and documentation in global regulatory environments.

Sample Preparation Techniques: Effective sample preparation minimizes matrix effects (Chowdhury et al., 2021; Singh & Patel, 2018) and enhances sensitivity in LC-MS/MS workflows. Recent innovations include:

Solid Phase Extraction (SPE): Offers high specificity; ideal for plasma and serum matrices.

Protein Precipitation (PPT): Simple and high-throughput; best for routine bioanalysis.

Liquid-Liquid Extraction (LLE): Efficient for lipophilic drugs but labor-intensive.

Supported Liquid Extraction (SLE): Cleaner extracts with reduced emulsions.

Microextraction Techniques: Enable microscale sampling in pediatric and geriatric studies.

Challenges and Research Gaps: In addition to the challenges already discussed, the following are critical areas requiring further attention:

Cross-Reactivity in Biological Matrices: Some bioanalytical methods suffer from interferences due to endogenous compounds or metabolites that mimic target analytes, leading to false positives or inaccurate quantification ^{51, 52}.

Sample Volume Constraints in Pediatric and Geriatric Studies: Especially in neonates or elderly populations, obtaining large blood volumes for pharmacokinetic studies is ethically and logistically difficult, thus necessitating ultra-sensitive microsampling approaches ^{53, 77}.

Analytical Interference from Excipients in Complex Formulations: Co-formulated drugs or advanced delivery systems such as liposomes and nanoparticles often involve excipients that affect extraction and chromatographic separation ^{54, 55}.

High Cost and Technical Expertise Requirement: The deployment of LC-MS/MS methods requires costly equipment and trained personnel, limiting its adoption in low-resource settings ⁵⁶.

Global Regulatory Divergence: Discrepancies among regulatory bodies (FDA, EMA, ICH) in bioanalytical validation and documentation protocols can delay drug approval or require redundant testing ^{57, 74}.

Data Reproducibility and Audit Readiness: Ensuring data integrity, particularly with automated peak integration tools and LIMS platforms, is crucial for regulatory acceptance ^{69, 70}.

These challenges underscore the need for harmonized practices, robust method development strategies, and further integration of digital tools like AI to ensure quality and reproducibility in bioanalytical science.

Despite significant advances, several issues remain unresolved in antiviral and antibacterial bioanalysis:

• Matrix interference affecting accuracy and reproducibility ⁴.
• Inadequate stability-indicating methods for combination therapies.
• Lack of validated methods for novel antiviral-antibacterial blends (e.g., Ensitrelvir + Remdesivir).
• Low recovery in protein-rich samples due to poor extraction efficiency.
• Regulatory inconsistencies between ICH, FDA, and EMA for method harmonization.

Future Research Directions: Looking ahead, the field of bioanalytical science is poised for significant transformation through the integration of emerging technologies. Artificial Intelligence (AI) and Machine Learning (ML) will revolutionize chromatographic data processing by automating peak detection, baseline correction, and real-time error prediction ⁷³. Wearable biosensors and point-of-care diagnostics are expected to generate new categories of real-time data requiring ultra-sensitive analytical methods. The development of green bioanalytical methods that minimize solvent use and hazardous waste is gaining attention, aligning with global sustainability initiatives ⁸⁵. Additionally, regulatory bodies are shifting toward model-informed drug development (MIDD) frameworks that incorporate predictive simulations alongside experimental data.

Lastly, collaborative open-source platforms and global analytical method repositories will improve transparency, data sharing, and reproducibility across laboratories, enabling faster drug development cycles ^{52, 57}.

• Develop LC-MS/MS methods compatible with microsampling platforms ^{53, 77}.
• Explore nanoparticle and liposomal formulations and their analytical implications.
• Integrate bioanalytical workflows with AI/ML (Rahman et al., 2020) ⁷³ for peak identification and quality control.
• Establish shared repositories linking analytical methods with patented drug innovations.
• Focus on pediatric-specific method development using minimal sample volume.

Bioanalytical methods form the analytical backbone of drug discovery, development, and regulatory submission processes. They provide essential data for evaluating pharmacokinetics (PK), bioavailability, and therapeutic monitoring of drugs across diverse biological matrices. Analytical technologies such as HPLC and LC-MS/MS have evolved to meet increasing demands for sensitivity, accuracy, and robustness. These methods are vital not only for evaluating parent drugs and metabolites but also for ensuring.

Furthermore, the reliability of a bioanalytical method is determined by its compliance with international standards such as ICH Q2(R1), FDA, and EMA guidelines, ensuring reproducibility across laboratories. As the pharmaceutical industry increasingly adopts complex drug formulations such as nanomedicines, biosimilars, and targeted therapies, bioanalytical methods must be adapted and revalidated for these platforms ^{3, 69}. These efforts are supported by method harmonization

Overview and Importance of Bioanalytical Methods: Bioanalytical methods refer to the quantitative measurement of drugs and their metabolites in biological matrices such as blood, plasma, urine, or tissues. These methods are critical in pharmaceutical research for drug discovery, pharmacokinetics, toxicology, and therapeutic drug monitoring (TDM).

The primary reasons bioanalytical methods are preferred include:

• High sensitivity and specificity for detecting drugs at low concentrations.
• Essential for determining pharmacokinetic parameters like AUC, Cmax, Tmax, and half-life.
• Compliance with regulatory requirements for bioequivalence and approval studies.
• Ability to validate the stability and accuracy of drug formulations.

ACKNOWLEDGMENT: The authors express their gratitude to Chaitanya Deemed to be University, Hyderabad, for providing access to research facilities and academic resources essential for this work.

CONFLICT OF INTEREST: The authors declare no conflict of interest related to the content of this article.

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    How to cite this article:

    Khazi NT and Gandla K: Patent-integrated review on bioanalytical methods for recent antiviral and antibacterial drugs. Int J Pharm Sci & Res 2026; 17(1): 188-97. doi: 10.13040/IJPSR.0975-8232.17(1).188-97.

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