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<p>Lansoprazole (LAN) is a widely used proton pump inhibitor whose analytical determination remains challenging because of its acid lability, pH-dependent degradation, oxidative susceptibility, extensive metabolism, and low systemic concentrations. This review critically evaluates reported analytical methods for determining LAN and its major metabolites, including 5-hydroxylansoprazole and lansoprazole sulfone, in pharmaceutical formulations and biological matrices. Particular emphasis is placed on sensitivity, selectivity, stability-indicating capability, matrix compatibility, validation performance, and regulatory relevance. Conventional HPLC–UV methods remain useful for routine pharmaceutical quality control because of their simplicity, availability, and acceptable precision; however, their limited sensitivity restricts their application in biological matrices. LC–MS/MS provides the highest analytical performance for plasma and pharmacokinetic studies, offering superior selectivity, low detection limits, and simultaneous quantification of LAN and metabolites. Spectroscopic and electrochemical approaches offer cost-effective, greener alternatives, but matrix interference, reproducibility issues, and insufficient validation in complex samples limit their broader application. Overall, this review highlights that no single analytical platform is universally optimal; method selection should depend on the matrix, analytical purpose, required sensitivity, and stability requirements. Future research should focus on validated green, miniaturized, high-throughput, and intelligent analytical systems to improve the reliability, sustainability, and clinical applicability of LAN analysis.</p>

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Analytical determination of lansoprazole and its metabolites: a critical review

  • 期刊论文

  • 发表日期：

    2026年7月22日

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  • Hemn A. H. Barzani,
  • Rebaz Anwar Omer,
  • Nergz Bayiz Abdulrahman,
  • Hunar Yasin Muhammad,
  • Ali Sedeeq Noaman,
  • Seerwan Hamadameen Sulaiman

摘要

Lansoprazole (LAN) is a widely used proton pump inhibitor whose analytical determination remains challenging because of its acid lability, pH-dependent degradation, oxidative susceptibility, extensive metabolism, and low systemic concentrations. This review critically evaluates reported analytical methods for determining LAN and its major metabolites, including 5-hydroxylansoprazole and lansoprazole sulfone, in pharmaceutical formulations and biological matrices. Particular emphasis is placed on sensitivity, selectivity, stability-indicating capability, matrix compatibility, validation performance, and regulatory relevance. Conventional HPLC–UV methods remain useful for routine pharmaceutical quality control because of their simplicity, availability, and acceptable precision; however, their limited sensitivity restricts their application in biological matrices. LC–MS/MS provides the highest analytical performance for plasma and pharmacokinetic studies, offering superior selectivity, low detection limits, and simultaneous quantification of LAN and metabolites. Spectroscopic and electrochemical approaches offer cost-effective, greener alternatives, but matrix interference, reproducibility issues, and insufficient validation in complex samples limit their broader application. Overall, this review highlights that no single analytical platform is universally optimal; method selection should depend on the matrix, analytical purpose, required sensitivity, and stability requirements. Future research should focus on validated green, miniaturized, high-throughput, and intelligent analytical systems to improve the reliability, sustainability, and clinical applicability of LAN analysis.