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August 31, 2026Separation Science Plus

Development and Validation of Stability‐indicating Simultaneous Reverse‐Phase High‐Performance Liquid Chromatography Method for Olmesartan Medoxomil and Azelnidipine in Combination: A Computational Approach Toward Greenness

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Authors

MMMeera MaruKSKetan Shah

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Overview

Laboratory validation study demonstrates an eco-friendly RP-HPLC assay for combined olmesartan medoxomil and azelnidipine, indicating reliable stability testing with minimal environmental impact.

Key Points

  • To develop and validate a stability-indicating, environmentally sustainable reverse-phase HPLC method for simultaneous quantification of olmesartan medoxomil and azelnidipine.
  • Separation was performed on a C18 column (150 mm × 4.6 mm, 5 µm) at room temperature using an isocratic mobile phase of 0.05 M ammonium formate buffer (pH 3.5) and methanol (30:70 %v/v) detected at 262 nm.
  • Method validation followed ICH guidelines across precision, accuracy, LOD, LOQ, robustness, and forced degradation under acidic, basic, oxidative, photolytic, and thermal stress.
  • Greenness assessment of the analytical workflow was computationally evaluated to quantify environmental sustainability relative to reported procedures.
  • Retention times were 3.71 min for olmesartan medoxomil and 5.39 min for azelnidipine, with linear detector responses across 10–30 µg/mL and 4–12 µg/mL, respectively (R² = 0.999 for both).
  • Mean recovery values ranged between 99.33% and 101.43%, with precision, LOD, LOQ, and robustness satisfying ICH acceptance criteria.
  • Forced degradation confirmed chromatographic resolution of both drugs from stress-induced degradation products alongside superior analytical greenness scores.

Cite This Study

Maru et al. (2026) studied this question.

synapsesocial.com/papers/6a95427bf20e493292a74da3https://doi.org/10.1002/sscp.70294
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