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Mediterranean Journal of Pharmacy and Pharmaceutical Sciences
https://app.periodikos.com.br/journal/medjpps/article/doi/10.5281/zenodo.18790443

Mediterranean Journal of Pharmacy and Pharmaceutical Sciences

Original article Medicinal chemistry

Stability-indicating RP-HPLC method development and validation for quantitative determination of Dexlansoprazole in bulk drug and dual delayed-release capsule

Muhammad Akhlaq, Hafiz M. Tariq, Aisha Siddiqua, Muhammad H. Jalal

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Abstract

A simple, precise, and stability-indicating RP-HPLC method was developed and validated for the quantitative determination of Dexlansoprazole in bulk drug and capsule dosage form. Chromatographic separation was achieved on an Inertsil ODS C18 column (250.0 x 4.6 mm, 5.0 um) using a mobile phase of phosphate buffer (pH 7.0) and acetonitrile (55: 45 v/v) at a flow rate of 1.0 ml/min with UV detection at 285 nm. The method was validated in accordance with the ICH guidelines for specificity, linearity, precision, accuracy, and robustness, range, and system suitability. The method exhibited excellent specificity with no interference from excipients or degradation products. Linearity was observed over the selected concentration range with a high correlation coefficient. Precision and accuracy studies showed relative standard deviation values within acceptable limits, confirming methods reliability. Robustness testing demonstrated the method's consistency under small deliberate variations. The validated method is suitable for routine quality control analysis of Dexlansoprazole in bulk and capsule formulation.

Keywords

Dexlansoprazole, method validation, stability-indicating method

References

  1. Jalihal U, Mahapatra JR, Kumar A, Bharadwaj T, Singh HD, Mehta V, et al. Comparative efficacy of dexlansoprazole, pantoprazole, esomeprazole, and rabeprazole in achieving optimal 24-hour intragastric pH control: A randomized crossover study using ambulatory pH monitoring. Cureus. 2024; 16(10): e71418. doi: 10.7759/cureus.71418
  2. Skrzydło-Radomańska B, Radwan P. Dexlansoprazole - a new-generation proton pump inhibitor. Przeglad Gastroenterology. 2015; 10(4): 191-196. doi: 10.5114/pg.2015.56109
  3. Goh KL, Choi MG, Hsu PI, Chun HJ, Mahachai V, Kachintorn U, et al. Pharmacological and safety profile of Dexlansoprazole: A new proton pump  inhibitor - implications for treatment of gastroesophageal reflux disease in the Asia Pacific Region. Journal of Neurogastroenterology and Motility. 2016; 22(3): 355-366. doi: 10.5056/ jnm15150
  4. Fass R, Frazier R. The role of dexlansoprazole modified-release in the management of  gastroesophageal reflux disease. Therapeutic Advances in Gastroenterology. 2017; 10(2): 243-251. doi: 10.1177/1756283X16681701
  5. Metz D, Vakily M, Dixit T, Mulford D. Dual delayed release formulation of dexlansoprazole MR, a novel approach to overcome the limitations of conventional single release proton pump inhibitor therapy. Alimentary Pharmacology and Therapeutics. 2009; 29: 928-937. doi: 10.1111/j.1365-2036.2009.03984.x
  6. Uddin MN. Long-term use of proton pump inhibitors: Possible unwanted effects and mitigation strategies. Mediterranean Journal of Medicine and Medical Sciences. 2026; 2(1): 36-39. doi: 10.5281/zenodo.18651656
  7. Lee RD, Vakily M, Mulford D, Wu J, Atkinson SN. Clinical trial: The effect and timing of food on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR, a novel dual delayed release formulation of a proton pump inhibitor-evidence for dosing flexibility. Alimentary Pharmacology and Therapeutics. 2009; 29(8): 824-833. doi: 10.1111/j.1365-2036.2009.03979.x
  8. Yanamadala G, Srikumar P, Rushyendra GV, Ramamohanupta V, Srinivasarao S. Stability indicating validated novel RP-HPLC method for the estimation of Dexlansprazole in bulk and extended release capsules. Indo American Journal of Pharmaceutical Research. 2013; 3(10): 8457-8464. doi: Nil.
  9. Bhole R, Bonde C, Girase G, Gurav S. Stability indicating validated novel RP-HPLC method for Dexlansoprazole and LC-MS/MS study of degradation product. Palestinian Medical and Pharmaceutical Journal. 2024; 9(1): 81-106. doi: 10.59049/2790-0231.1128
  10. Hassan M, Alkhalidi O, Al Hasseny RJH, Abes SM. GC-MS profiling of volatile metabolites produced by Enterococcus faecalis and evaluation of its antibacterial and antifungal activity. Journal of Current Medical Research and Opinion. 2024; 7(4): 2294-2303. doi: 10.52845/CMRO/2024/7-4-13
  11. Elnekaib MA, Musa KAK, Almdaaf MA. The role of High-Performance Liquid Chromatography in the pharmaceutical analysis. Mediterranean Journal of Pharmacy and Pharmaceutical Sciences. 2025; 5(3): 57-62. doi: 10.5281/zenodo.16748956
  12. Hamache T, Belboukhari N, Sekkoum K, Ghouizi M. Chiral screening approach of atorvastatin diastereomers by HPLC method. Mediterranean Journal of Pharmacy and Pharmaceutical Sciences. 2024; 4(1): 121-125. doi: 10.5281/zenodo.10814722
  13. Darokar SY, Borade B, Thorat SR, Khade RV, Faizan S. Validation of forced degradation and stability indicating studies of nanoformulation using Spectroscopic technique. Mediterranean Journal of Medical Research. 2026; 3(1): 67-78. doi: 10.5281/zenodo.18790410
  14. Gajra B, Patel M, Patel D. Validation of analytical procedures: Methodology ICH-Q2B. International Journal of Pharmaceutical Innovations. 2011; (2)1: 45-50. doi: Nil.
  15. Ghari T, Kobarfard F, Mortazavi S. Development of a simple RP-HPLC-UV method for determination of azithromycin in bulk and pharmaceutical dosage forms as an alternative to the USP method. Iranain Journal of Pharmaceutical Research. 2013; 12(Supp.). 57-63. PMID: 24250672; PMCID: PMC3813375.
  16. Patel JK, Vaishnav R. Analytical method validation of compendial HPLC method for pharmaceuticals as per recent USP and ICH guidelines. The Pharmaceutical and Chemical Journal. 2025; 12(4): 90-95. doi: Nil.
  17. Awatade PR, Veer VS, Kasabe AJ, Dhepe SD. Analytical method development and validation of rivaroxaban in bulk and pharmaceutical dosage form by using RP-HPLC. International Journal of Health Sciences. (Qassim). 2022; 8(6): 14688-14702. doi: 10.53730/ijhs.v6ns2.8879
  18. Pandya D, Patel C, Patel K. Quality by design based stability indicating quantitative reverse phase High Performance Liquid Chromatography method development and validation for bilastine in tablet dosage form. Indian Journal of Pharmaceutical Sciences. 2024; 86: 683-691. doi: 10.36468/pharmaceutical-sciences.1323
  19. Singh B, Trivedi N, Kumar A, Kumer V. Eco-friendly HPLC Strategies for pharmaceutical analysis eco-friendly approaches for HPLC solvent selection instruments for assessing the eco-friendliness of chromatographic techniques. Journal of Advanced Scientific Research. 2025; 16(5): 6-13. doi: 10.55218/JASR.2025160502
  20. Haneef M, Rajkamal B, Tharun DG, Goud M. Development and validation by RP-HPLC method for estimation of zidovudine in bulk and its pharmaceutical dosage form. Asian Journal of Research Chemistry. 2013; 6(4): 341-344. doi: Nil.
  21. Bilal A, Rehman K, Akash MSH, Hussain K, Ibrahim M, Hussan S. Development and validation of analytical method for qualitative and quantitative determination of glibenclamide in different brands of tablet dosage form using UV-Visible Spectroscopy. Journal of Molecular Genetic Medicine. 2013; 7: 3. doi: 10.4172/1747-0862. 1000080
  22. Ermer J. Validation in pharmaceutical analysis. Part I: An integrated approach. Journal of Pharmaceutical and Biomedical Analysis. 2001; 24: 755-767. doi: 10.1016/S0731-7085(00)00530-6
  23. Shrivastava A. Methods for the determination of limit of detection and limit of quantitation of the analytical methods. Chronicles of Young Scientists. 2011; 2: 21-25. doi: 10.4103/2229-5186.79345
  24. Desai N, Momin M, Singh U, Khan T, Sherje A. Analytical method development and validation for simultaneous estimation of curcumin and cyclosporine by RP-HPLC. International Journal of Pharmacy and Pharmaceutical Sciences. 2018; 11(2): 26-33. doi: 10.22159/ijpps.2019v11i2.28975
  25. Akhlaq M, Khan GM, Wahab A, Khan A, Hussain A, Nawaz A, Abdelkader H. A simple high-performance liquid chromatographic practical approach for determination of flurbiprofen. Journal of Advanced Pharmaceutical and Technology and Research. 2011; 2: 151-155. doi: 10.4103/2231-4040.85529

Submitted date:
12/26/2025

Reviewed date:
02/20/2026

Accepted date:
02/23/2026

Publication date:
02/26/2026

69a08fdfa9539549a440bbd4 medjpps Articles
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Mediterr J Pharm Pharm Sci

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