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Background <p>Alendronate sodium, a first‑line bisphosphonate for osteoporosis, presents major analytical challenges due to its high polarity and lack of a native UV chromophore, typically necessitating derivatization‑based detection.</p> Objective <p>To develop and validate a simple, rapid, derivatization‑free RP‑HPLC method for the direct quantification of alendronate sodium in tablet formulations, aligned with green analytical chemistry principles, and to comprehensively evaluate its stability‑indicating capability and column reproducibility.</p> Methods <p>Chromatographic separation was achieved on a Kromasil Eternity C18 column using an isocratic mobile phase of 20 mM ammonium formate buffer (pH 2.8) and methanol (90:10, v/v), with UV detection at 260 nm and a 5‑minute run time. Method validation followed ICH Q2(R2) guidelines. Forced degradation studies under acid, base, oxidative, thermal, and photolytic conditions were conducted to confirm stability‑indicating performance. Column reproducibility was assessed across three different C18 brands and batches. Environmental sustainability was evaluated using NEMI, ComplexGAPI, and RGB12 tools.</p> Results <p>The method demonstrated excellent linearity (5–1000 µg/mL; r² = 0.998), sensitivity (LOD 0.21 µg/mL; LOQ 0.65 µg/mL), accuracy (98.7–100.4%), and precision (RSD &lt; 2%). Forced degradation studies confirmed stability‑indicating capability, with alendronate peaks fully resolved from all degradation products (Rs &gt; 4.0) and peak purity indices exceeding 0.9995. Column reproducibility was satisfactory across different C18 columns and batches. Commercial formulations complied with pharmacopoeial limits (95–105%). Green metrics confirmed minimal solvent consumption and reduced hazardous waste.</p> Conclusion <p>This work introduces a validated, derivatization-free, stability-indicating analytical platform that overcomes the long-standing challenges of alendronate quantification. Its simplicity, speed, robustness across columns, and confirmed eco‑friendliness make it a superior, sustainable alternative to conventional methods for routine pharmaceutical quality control.</p> Graphical Abstract <p></p>

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A Validated Green RP-HPLC Method for Direct Determination of Alendronate Sodium in Pharmaceutical Formulations

  • 期刊论文

  • 发表日期：

    2026年5月30日

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  • Hassan A. Rudayni,
  • Ahmed A. Allam,
  • Abdelatty M. Radalla,
  • Rehab Mahmoud,
  • Samar M. Mahgoub

摘要

Background

Alendronate sodium, a first‑line bisphosphonate for osteoporosis, presents major analytical challenges due to its high polarity and lack of a native UV chromophore, typically necessitating derivatization‑based detection.

Objective

To develop and validate a simple, rapid, derivatization‑free RP‑HPLC method for the direct quantification of alendronate sodium in tablet formulations, aligned with green analytical chemistry principles, and to comprehensively evaluate its stability‑indicating capability and column reproducibility.

Methods

Chromatographic separation was achieved on a Kromasil Eternity C18 column using an isocratic mobile phase of 20 mM ammonium formate buffer (pH 2.8) and methanol (90:10, v/v), with UV detection at 260 nm and a 5‑minute run time. Method validation followed ICH Q2(R2) guidelines. Forced degradation studies under acid, base, oxidative, thermal, and photolytic conditions were conducted to confirm stability‑indicating performance. Column reproducibility was assessed across three different C18 brands and batches. Environmental sustainability was evaluated using NEMI, ComplexGAPI, and RGB12 tools.

Results

The method demonstrated excellent linearity (5–1000 µg/mL; r² = 0.998), sensitivity (LOD 0.21 µg/mL; LOQ 0.65 µg/mL), accuracy (98.7–100.4%), and precision (RSD < 2%). Forced degradation studies confirmed stability‑indicating capability, with alendronate peaks fully resolved from all degradation products (Rs > 4.0) and peak purity indices exceeding 0.9995. Column reproducibility was satisfactory across different C18 columns and batches. Commercial formulations complied with pharmacopoeial limits (95–105%). Green metrics confirmed minimal solvent consumption and reduced hazardous waste.

Conclusion

This work introduces a validated, derivatization-free, stability-indicating analytical platform that overcomes the long-standing challenges of alendronate quantification. Its simplicity, speed, robustness across columns, and confirmed eco‑friendliness make it a superior, sustainable alternative to conventional methods for routine pharmaceutical quality control.

Graphical Abstract