The pharmaceutical industry requires highly reliable

The gap

Evidence profile

Sourced from the stated research gap and future work of the source papers, classified as general, all from Zenodo (CERN European Organization for Nuclear Research).

Supporting evidence — 3 representative gaps

• REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (RP- HPLC) BASED ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR PHARMACEUTICAL DOSAGE FORMS: A COMPREHENSIVE REVIEW (2026) · Zenodo (CERN European Organization for Nuclear Research) · doi

  The pharmaceutical industry requires highly reliable analytical techniques to ensure product safety and clinical efficacy. There is a need for a comprehensive review of RP-HPLC method development and validation for pharmaceutical dosage forms. The industry is shifting away from traditional trial-and-error testing toward Analytical Quality by Design (AQbD).

  generalstated research gap
  Keywords: pharmaceutical industry requires highly reliable analytical techniques ensure
• Analytical Method Development and Validation Methods for Estimation of Drugs in Pharmaceutical Dosage Forms: A Review (2026) · Zenodo (CERN European Organization for Nuclear Research) · 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.

  generalfuture workevidence 5/5
  Keywords: hplc development pharmaceutical review application chemistry analytical validation conflict author international journal fdcs including driven
• ANALYTICAL QUALITY BY DESIGN (AQBD) BASED DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR FAVIPIRAVIR (2026) · Zenodo (CERN European Organization for Nuclear Research) · doi

  Future developments may include:  Advanced chemometric tools  Artificial intelligence-assisted optimization  Real-time analytical monitoring  Continuous manufacturing integration  Automated method lifecycle management 13. CONCLUSION Analytical Quality by Design provides a systematic and efficient framework for RP-HPLC method development and validation for Favipiravir. Through the integration of risk assessment, Design of Experiments, and robust validation strategies, AQbD ensures reliable analytical performance and regulatory compliance. Compared with conventional approaches, AQbD-based methods offer superior robustness, enhanced process understanding, and improved lifecycle management. Consequently, AQbD has become an indispensable tool in modern pharmaceutical analytical development. www.wjpps.com │ Vol 15, Issue 7, 2026. │ ISO 9001:2015 Certified Journal │ 1173 Jadhav. World Journal of Pharmacy and Pharmaceutical Sciences REFERENCES 1. International Council for Harmonisation (ICH). Q14 Guideline on Analytical Procedure Development. Geneva; 2023. 2. International Council for Harmonisation (ICH). Q2(R2) Validation of Analytical Procedures. Geneva; 2023. 3. International Council for Harmonisation (ICH). Q8(R2) Pharmaceutical Development. Geneva. 4. International Council for Harmonisation (ICH). Q9 Quality Risk Management. Geneva. 5. International Council for Harmonisation (ICH). Q10 Pharmaceutical Quality System. Geneva. 6. Yu LX. Pharmaceutical Quality by Design: Product and Process Development, Understanding and Control. Pharmaceutical Research. 2008; 25(4): 781–791. 7. Rozet E, Hubert P, Ceccato A. Analytical Quality by Design: Method Development and Validation. Journal of Pharmaceutical and Biomedical Analysis. 2011; 55(4): 848–858. 8. Beg S, Sharma G, Katare OP. Analytical Quality by Design Approach in Pharmaceutical Method Development. Journal of Chromatographic Science. 2015; 53(5): 662–673. 9. Shirsat A, et al. Development and Validation of RP-HPLC Method for Favipiravir Estimation in Pharmaceutical Dosage Forms. International Journal of Pharmaceutical Sciences and Research. 2021. 10. Chandran S, Singh RSP. AQbD-Based RP-HPLC Method Development for Antiviral Drugs: Current Trends and Applications. International Journal of Pharmaceutical Research. 2022. www.wjpps.com │ Vol 15, Issue 7, 2026.

  generalfuture workevidence 5/5
  Keywords: pharmaceutical development analytical journal international quality design validation council harmonisation geneva aqbd management hplc integration

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