Analytical Method Development and Validation for the Quantification of Related Substances in Pantoprazole Gastro-Resistant Tablets by RP-HPLC: A Critical Review
- 1Department of Pharmaceutical Analysis, C.L. Baid Metha College of Pharmacy, Thoraipakkam, Chennai-6000097, Tamil Nadu, India
Abstract
Pantoprazole sodium is a benzimidazole-class proton-pump inhibitor used widely in the management of gastro-oesophageal reflux disease, peptic ulcers, and Zollinger–Ellison syndrome. Because the molecule is acid-labile and oxidation-sensitive, it is formulated as an enteric-coated, gastro-resistant tablet, and its impurity profile must be tightly controlled to meet ICH Q3B(R2) thresholds. This review critically appraises the peer-reviewed literature on reversed-phase high-performance liquid chromatography (RP-HPLC) methods for the quantification of related substances in pantoprazole gastro-resistant tablets and converges on best-practice conditions for new method developers. A structured literature search of PubMed, Scopus, Web of Science, and ScienceDirect (January 2005–December 2025) was conducted following PRISMA 2020 guidance. Thirteen primary analytical studies and twelve regulatory or methodological documents (ICH guidelines, USP and Ph. Eur. monographs, PRISMA 2020, AGREE, GAPI and BAGI tool descriptors, plus PubChem records) were included after screening 84 records. The dominant RP-HPLC configuration uses a C18 stationary phase (250 × 4.6 mm, 5 µm) with a phosphate-buffered (pH 7.0–7.4) mobile phase, acetonitrile as the organic modifier, 1.0 mL min −1 flow, 290 nm UV detection, and a 35°C column temperature. Methods coupling pantoprazole with a partner analyte shift to 239 nm for shared sensitivity. LC–MS/MS is required for genotoxic-impurity profiling below 1 ppm. Green-analytical metrics (AGREE, GAPI, BAGI) and Analytical Quality by Design (AQbD) workflows are emerging but unevenly reported. RP-HPLC remains the workhorse technique for pantoprazole impurity profiling, but the literature is heterogeneous in column temperature, mobile-phase pH, and validation reporting. Standardised reporting of mass balance, AQbD design space, and greenness scores will materially advance the field.
Related
- Simultaneous quantification of Minoxidil and Dexpanthenol in topical solutions: Development and validation of a RP-HPLC procedure
- Development and validation of the analytical method for determination of residual solvents (2-propanol and n-hexane) in the drug substance Inosine Pranobex.
- Development and validation of a novel candidate reference procedure for the quantification of 3-nitro-L-tyrosine, 3-monoiodo-L-tyrosine and 3,5-diiodo-L-tyrosine in urine by isotope dilution and LC-ESI-MS/MS
- Development and validation of an RP-HPLC method for the quantification of residual 7-chloroquinaldine impurity in alkene aldehyde intermediate of montelukast sodium
- Extraction Strategies for Per- and Polyfluoroalkyl Substances (PFAS): A Critical Comparative Framework Integrating Sensitivity, Sustainability, and Analytical Trade-offs
BibTeX
@article{abirami2026analytical,
title = {{Analytical Method Development and Validation for the Quantification of Related Substances in Pantoprazole Gastro-Resistant Tablets by RP-HPLC: A Critical Review}},
author = {Abirami A and Prarthana J and Surya R and Bharani Pandilla},
journal = {International Journal of Research in Pharmaceutical Sciences},
year = {2026},
month = jun,
doi = {10.26452/ijrps.v17i2.4418},
url = {https://doi.org/10.26452/ijrps.v17i2.4418},
note = {CC BY},
}
RIS
TY - JOUR
TI - Analytical Method Development and Validation for the Quantification of Related Substances in Pantoprazole Gastro-Resistant Tablets by RP-HPLC: A Critical Review
AU - Abirami A
AU - Prarthana J
AU - Surya R
AU - Bharani Pandilla
PY - 2026
DA - 2026/06/01
JO - International Journal of Research in Pharmaceutical Sciences
DO - 10.26452/ijrps.v17i2.4418
UR - https://doi.org/10.26452/ijrps.v17i2.4418
AB - Pantoprazole sodium is a benzimidazole-class proton-pump inhibitor used widely in the management of gastro-oesophageal reflux disease, peptic ulcers, and Zollinger–Ellison syndrome. Because the molecule is acid-labile and oxidation-sensitive, it is formulated as an enteric-coated, gastro-resistant tablet, and its impurity profile must be tightly controlled to meet ICH Q3B(R2) thresholds. This review critically appraises the peer-reviewed literature on reversed-phase high-performance liquid chromatography (RP-HPLC) methods for the quantification of related substances in pantoprazole gastro-resistant tablets and converges on best-practice conditions for new method developers. A structured literature search of PubMed, Scopus, Web of Science, and ScienceDirect (January 2005–December 2025) was conducted following PRISMA 2020 guidance. Thirteen primary analytical studies and twelve regulatory or methodological documents (ICH guidelines, USP and Ph. Eur. monographs, PRISMA 2020, AGREE, GAPI and BAGI tool descriptors, plus PubChem records) were included after screening 84 records. The dominant RP-HPLC configuration uses a C18 stationary phase (250 × 4.6 mm, 5 µm) with a phosphate-buffered (pH 7.0–7.4) mobile phase, acetonitrile as the organic modifier, 1.0 mL min −1 flow, 290 nm UV detection, and a 35°C column temperature. Methods coupling pantoprazole with a partner analyte shift to 239 nm for shared sensitivity. LC–MS/MS is required for genotoxic-impurity profiling below 1 ppm. Green-analytical metrics (AGREE, GAPI, BAGI) and Analytical Quality by Design (AQbD) workflows are emerging but unevenly reported. RP-HPLC remains the workhorse technique for pantoprazole impurity profiling, but the literature is heterogeneous in column temperature, mobile-phase pH, and validation reporting. Standardised reporting of mass balance, AQbD design space, and greenness scores will materially advance the field.
SN - 0975-7538
ER -