Scholarlink

Background <p>Pregabalin (PRG) and etoricoxib (ETO) are co‑formulated for neuropathic pain therapy owing to complementary mechanisms.</p> Objective <p>To develop and validate a green, stability‑indicating RP‑HPLC method for simultaneous quantification of PRG and ETO in tablets.</p> Methods <p>Analysis was performed on a C18 column (250 × 4.6&#xa0;mm, 5&#xa0;μm) using methanol–phosphate buffer (pH 7, 60:40 v/v) at 1.0 mL/min flow rate with UV detection at 210&#xa0;nm. The method was validated per ICH Q2(R2). Forced degradation (acid, base, oxidative, neutral, thermal, photolytic) was performed. Environmental impact was assessed via AGREE, AGREEprep, ComplexGAPI, and BAGI.</p> Results <p>Retention times: PRG at 3.02&#xa0;min, ETO at 4.87&#xa0;min (resolution = 4.32). Linearity was observed in 25–200&#xa0;µg/mL (R² &gt; 0.995). LOD/LOQ: PRG = 0.13/0.39&#xa0;µg/mL; ETO = 0.47/1.42&#xa0;µg/mL. Recoveries ranged from 99.0 to 99.31% (PRG) and 98.0–99.5% (ETO). Intraday/interday RSD &lt; 1.7%. The method effectively separated analytes from degradation products. Greenness scores: AGREE = 0.78, BAGI = 80, AGREEprep = 0.62, ComplexGAPI showed moderate greenness.</p> Conclusion <p>The method is rapid (&lt; 5&#xa0;min), accurate, precise, stability‑indicating, and eco‑friendly—suitable for routine quality control of PRG–ETO formulations.</p> Graphical abstract <p></p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Greenness analysis of stability indicating RP-HPLC analytical method development and validation for simultaneous estimation of pregabalin and etoricoxib in pharmaceutical dosage form

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月22日

查看全文
  • Drashti Mandale,
  • Yukti Rana,
  • Riddhi Savaliya,
  • Nidhi Chauhan

摘要

Background

Pregabalin (PRG) and etoricoxib (ETO) are co‑formulated for neuropathic pain therapy owing to complementary mechanisms.

Objective

To develop and validate a green, stability‑indicating RP‑HPLC method for simultaneous quantification of PRG and ETO in tablets.

Methods

Analysis was performed on a C18 column (250 × 4.6 mm, 5 μm) using methanol–phosphate buffer (pH 7, 60:40 v/v) at 1.0 mL/min flow rate with UV detection at 210 nm. The method was validated per ICH Q2(R2). Forced degradation (acid, base, oxidative, neutral, thermal, photolytic) was performed. Environmental impact was assessed via AGREE, AGREEprep, ComplexGAPI, and BAGI.

Results

Retention times: PRG at 3.02 min, ETO at 4.87 min (resolution = 4.32). Linearity was observed in 25–200 µg/mL (R² > 0.995). LOD/LOQ: PRG = 0.13/0.39 µg/mL; ETO = 0.47/1.42 µg/mL. Recoveries ranged from 99.0 to 99.31% (PRG) and 98.0–99.5% (ETO). Intraday/interday RSD < 1.7%. The method effectively separated analytes from degradation products. Greenness scores: AGREE = 0.78, BAGI = 80, AGREEprep = 0.62, ComplexGAPI showed moderate greenness.

Conclusion

The method is rapid (< 5 min), accurate, precise, stability‑indicating, and eco‑friendly—suitable for routine quality control of PRG–ETO formulations.

Graphical abstract