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Open research questions in Analytical Methods in Pharmaceuticals

123 unresolved questions extracted from the limitations and future-work sections of 736 Analytical Methods in Pharmaceuticals papers in our library. Each links back to the study that raised it.

What the literature leaves open

  • The market unavailability of Bevyxxa capsules in Egypt - The use of compounded capsules prepared in the laboratory - The examination of a limited number of buffers and diluting solvents

    A novel sensitive and validated spectrofluorimetric framework for betrixaban determination in different matrices using erythrosine B–based fluorescence quenching · 2026 · DOI

  • Further studies to explore the application of the method in other matrices - Investigation of the method’s potential for use in other analytical techniques - Development of new methods for the determination of betrixaban

    A novel sensitive and validated spectrofluorimetric framework for betrixaban determination in different matrices using erythrosine B–based fluorescence quenching · 2026 · DOI

  • There is a need for a new eco-friendly and reliable method for determining metronidazole benzoate. Prior methods have limitations, such as consuming expensive and environmentally hazardous reagents.

    Eco-friendly capillary gas chromatography with flame ionization detector (CGC-FID) to determine metronidazole benzoate in dosage forms · 2026 · DOI

  • The need for a robust and validated analytical method to assess Itraconazole stability under stress conditions. The lack of a sustainable RPHPLC method for the estimation of Itraconazole.

    Green chemistry integrated quality by design based RP-HPLC method for analysis of Itraconazole in pharmaceutical formulations · 2026 · DOI

  • The gel formulation showed 3% thermal and photolytic degradation compared to 5% and 4% in bulk drug, suggesting excipient stabilization; the specific excipient(s) responsible for this protection and their interaction mechanisms with Itraconazole have not been isolated or characterized through forced degradation studies with individual excipient components.

    Green chemistry integrated quality by design based RP-HPLC method for analysis of Itraconazole in pharmaceutical formulations · 2026 · DOI

  • The need for a robust and efficient method for quantifying pioglitazone and teneligliptin in dosage form. The lack of a sustainable and environmentally friendly method for quantifying these drugs.

    CCD-Based Quality by Design Strategy for RP-HPLC Method Development and Optimization for Quantifying Pioglitazone and Teneligliptin · 2026 · DOI

  • There is a lack of methods for the simultaneous quantification of cinnarizine, domperidone, and benzophenone. Existing methods are not environmentally sustainable and cost-effective.

    MATLAB-candexch algorithm-enhanced UV spectrophotometric-chemometric models for green, blue, and white determination of cinnarizine, domperidone, and carcinogenic impurity in pharmaceuticals: NQS assessment and UN-SDGs integration · 2026 · DOI

  • The significant spectral overlap prevents the quantification of the combined medications in Auvelity® tablets using a univariate spectrophotometric approach. Hazardous process-related contaminants need close monitoring. Traditional analytical techniques pose undesirable dangers to the environment and the analyst.

    Chemometric and learning-based multivariate models for quantifying a challenging quaternary mixture of bupropion, dextromethorphan, and their related impurities by UV-Vis spectrophotometry · 2026 · DOI

  • Few analytical methods for figuring out BUP and DEX in pharmaceutical formulations have been documented. No chemometric models for figuring out BUP and DEX mixtures in the presence of their official impurities have been presented.

    Chemometric and learning-based multivariate models for quantifying a challenging quaternary mixture of bupropion, dextromethorphan, and their related impurities by UV-Vis spectrophotometry · 2026 · DOI

  • There is a need for a precise and accurate method for the simultaneous determination of Phenobarbital and Phenytoin. The existing methods may not be suitable for routine quality control analysis of bulk and pharmaceutical formulations.

    Development and Validation of a RP-HPLC-PDA Method for Simultaneous Determination of Phenobarbital and Phenytoin in Pure Form and its Pharmaceutical Dosage Form · 2026 · DOI

  • Future trajectories point toward the integration of Artificial Intelligence (AI) and Machine Learning (ML) algorithms with AQbD workflows. The use of AI and ML algorithms can predict chromatographic behaviors and accelerate the method development lifecycle.

    ANALYTICAL QUALITY BY DESIGN (AQBD) IN THE DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC METHODS FOR FIXED-DOSE COMBINATIONS: A COMPREHENSIVE REVIEW · 2026 · DOI

  • The development of a singular, efficient, and robust chromatographic method for FDCs is challenging due to the divergent physicochemical properties of the APIs. There is a need for a systematic, risk-based methodology like AQbD for developing and validating chromatographic methods for FDCs.

    ANALYTICAL QUALITY BY DESIGN (AQBD) IN THE DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC METHODS FOR FIXED-DOSE COMBINATIONS: A COMPREHENSIVE REVIEW · 2026 · DOI

  • The estimation of multi-component drug formulations is challenging due to overlapping spectra and matrix interference. There is a need for comprehensive review of analytical methods for simultaneous estimation of multi-component drug formulations.

    Analytical Techniques for Simultaneous Estimation of Multi-Component Drug Formulations: A Comprehensive Review · 2026 · DOI

  • There is a need for a robust and specific RP-HPLC method for the quantification of dronedarone HCl. The existing methods may not be accurate, precise, and sensitive.

    Rp-Hplc Method Development And Validation Of By Using Qbd Approach · 2026 · DOI

  • The need for reliable analytical procedures for quality control and regulatory compliance. The lack of a streamlined resource for researchers and analysts to choose and create trustworthy analytical techniques.

    Analytical Method Development and Validation Methods for Estimation of Drugs in Pharmaceutical Dosage Forms: A Review · 2026 · DOI

  • in FDCs, including QbD-driven, application By advancing this technique for a variety of processes, green stability chemistry, indicating assays, and complex formulations like nano and lipid-based dosage forms, there are opportunities to develop and validate analytical methods for both single and simultaneous drug quantification in the future. Process Analytical Technology (PAT) and real-time release testing are used to optimise columns and integrate spectroscopic or at-line/online HPLC with chemometrics for continuous batch production. More reliable method development and validation by RP-HPLC are needed due to the growing number of diseases and the demanding nature of complicated formulation. CONFLICT OF INTERSECT The author declares no conflict of interest. No financial support or relationship with entities that could influence the work were received. ACKNOWLEDGEMENTS The Hygia Institute of Pharmaceutical Education and Research's Department of Pharmaceutical Chemistry is acknowledged by the author for supplying the materials and literature database that were necessary for this review. REFERENCES 1. Madhavai S. A Review on Chromatographic Techniques and their Application in Analysis of Pharmaceuticals. International Journal of Novel Research and Development. 2024 Feb;9(2):580–90. 2. Snyder LR, Kirkland JK, Glajch LJ. Practical HPLC Method Development. Second. New INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES 2278 | P a g e Syed Tahir Hussain Rizvi, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 5, 2265-2283 | Review York: John Wiley & Sons, Inc.; 1997. doi:10.1002/9781118592014 3. Sailaja A, Nagamallika G.

    Analytical Method Development and Validation Methods for Estimation of Drugs in Pharmaceutical Dosage Forms: A Review · 2026 · DOI

  • Overlap of the drugs' emission spectra. Need for a method that is sensitive, simple, and selective. Requirement for minimal solvent consumption and handling.

    Eco-friendly second-derivative synchronous fluorescence method for the determination of empagliflozin and sitagliptin in tablets and plasma samples · 2026 · DOI

  • Conventional spectrofluorimetric techniques are limited for simultaneous analysis of empagliflozin and sitagliptin. There is a need for a sensitive, simple, and selective method for their determination.

    Eco-friendly second-derivative synchronous fluorescence method for the determination of empagliflozin and sitagliptin in tablets and plasma samples · 2026 · DOI

  • There is a need for a simple, accessible, and feasible method for the quantitative measurement of paracetamol. The current methods for determining paracetamol are complex and time-consuming.

    Optimization and Validation of a Rapid Spectrophotometric Method for the Determination of Paracetamol in Pure and Human Dosage Forms · 2026 · DOI

  • The successful development and analytical validation of this HPMC-based matrix tablet open multiple advanced translational pathways. Given the well-documented circadian rhythm of cardiovascular emergencies— specifically the dangerous spike in blood pressure and myocardial infarctions during the early morning hours— future research could pivot this SR formulation toward Chronotherapeutic Drug Delivery. By modifying the outer polymer coatings, the system could be engineered as a delayed-pulsatile release tablet taken at bedtime, programmed to release its maximum Propranolol load just prior to awakening. Furthermore, transitioning from traditional wet granulation to advanced Quality by Design (QbD) optimization, combined with continuous © 2026 The Author(s). Published by IJCOPE Journal. Website: https://ijcope.org/ 12 International Journal of Creative and Open Research in Engineering and Management ISSN: 3108-1754 (Online) Volume 02 Issue 05 May-2026 | Impact Factor: 3.5 manufacturing paradigms or 3D pharmaceutical printing, could allow for highly personalized dosing modifications. Most immediately, the robust in-vitro kinetic data acquired here sets the foundational baseline required to establish a Level A In Vitro-In Vivo Correlation (IVIVC), paving the way for targeted human pharmacokinetic trials and regulatory bioequivalence submissions.

    Method Development and Validation of Sustained Release Tablets of Propranolol Hydrochloride · 2026 · DOI

  • The need for a reliable and efficient method for simultaneous estimation of Metformin hydrochloride, Sitagliptin phosphate, and Dapagliflozin monohydrate. The lack of a validated RP-HPLC method for routine quality control analysis of fixed-dose combination tablets.

    Development and Validation of a RP-HPLC Method for the Simultaneous Estimation of Metformin Hydrochloride, Sitagliptin Phosphate and Dapagliflozin Monohydrate in Fixed-Dose Combination Tablets · 2026 · DOI

  • The need for reliable analytical techniques for simultaneous estimation of Tetrabenazine and Amlodipine besylate. The lack of a simple, accurate, and cost-effective method for simultaneous estimation.

    METHOD DEVELOPMENT FOR SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF TETRABENAZINE AND AMLODIPINE BESYLATE DRUG · 2026 · DOI

  • There are no logical strategies announced for the estimation deferiprone by RP-HPLC strategy.

    ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR DEFERIPRONE IN BULK AND TABLET DOSAGE FORM BY USING RP-HPLC METHOD · 2026 · DOI

  • The need for reliable analytical methods for drug estimation and quality control. The challenge of simultaneous estimation of Nimesulide and Diclofenac in pharmaceutical dosage forms.

    METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF NIMESULIDE & DICLOFENAC IN PHARMACEUTICAL FORMULATIONS WITH THE HELP OF UV-VISIBLE SPECTROSCOPY: A REVIEW · 2026 · DOI

  • There is a need for a chemometric assisted technique with QbD approach for the estimation of telmisartan and hydrochlorothiazide from combined formulation. The existing methods have limitations, such as lack of robustness and efficiency.

    AN IMPROVED CHEMOMETRIC ASSISTED TECHNIQUE WITH QBD APPROACH FOR ESTIMATION OF TELMISARTAN AND HYDROCHLOROTHIAZIDE FROM COMBINED FORMULATION · 2026 · DOI

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123 open questions have been extracted from the limitations and future-work passages of 736 Analytical Methods in Pharmaceuticals papers in our library. Each one below links back to the study that raised it, so you can read the original claim in context.

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