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<p>Hypertension is a common issue nowadays globally. About 1.28 billion adults aged 30–79&#xa0;years worldwide are suffering from hypertension according to the World Health Organization (WHO). A newer Phase III combination containing a calcium-channel blocker, angiotensin-II receptor blocker, and β-blocker is amlodipine besylate, telmisartan, and bisoprolol fumarate, respectively, indicating its antihypertensive property. The proposed study reflects a validated instrumental thin-layer chromatography (TLC) method for the quantification of all three drugs in bulk and in a fixed-dose synthetic mixture. The polar stationary phase containing precoated silica gel G60 F<sub>254</sub> aluminium sheet (10 × 10&#xa0;cm, 0.2&#xa0;mm layer thickness) was selected with ethyl acetate‒methanol‒25% ammonia (9:1:1, <i>V/V</i>) as the optimized mobile phase. Very well-resolved peaks of all three drugs were obtained at <i>R</i><sub>F</sub> values of 0.23, 0.51, and 0.63 for telmisartan, amlodipine besylate, and bisoprolol fumarate, respectively, at an analytical wavelength of 229&#xa0;nm. A linear relationship was observed for the concentration range of 1600‒9600&#xa0;ng/band for telmisartan, 200‒1200&#xa0;ng/band for amlodipine besylate, and 200‒1200&#xa0;ng/band for bisoprolol fumarate. The correlation coefficients (<i>r</i><sup>2</sup>) for telmisartan, amlodipine besylate and bisoprolol fumarate were found to be 0.996, 0.999, and 0.997, respectively. The method was validated for various parameters as per the International Council for Harmonization (ICH) Q2 (R2) guidelines and was found to be robust, accurate, precise, reproducible, and sensitive for the simultaneous quantification of all three drugs in bulk and in a fixed-dose synthetic mixture.</p>

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Instrumental thin-layer chromatography method for the estimation of phase III newer antihypertension combination of amlodipine besylate, bisoprolol fumarate, and telmisartan in fixed-dose synthetic mixture with greenness evaluation

  • 期刊论文

  • 发表日期：

    2025年5月21日

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  • Sakshi Patel,
  • Hiral Rohit,
  • Lisa Patel,
  • Nikul Raval,
  • Hetaben Kachhiya,
  • Jinal Tandel

摘要

Hypertension is a common issue nowadays globally. About 1.28 billion adults aged 30–79 years worldwide are suffering from hypertension according to the World Health Organization (WHO). A newer Phase III combination containing a calcium-channel blocker, angiotensin-II receptor blocker, and β-blocker is amlodipine besylate, telmisartan, and bisoprolol fumarate, respectively, indicating its antihypertensive property. The proposed study reflects a validated instrumental thin-layer chromatography (TLC) method for the quantification of all three drugs in bulk and in a fixed-dose synthetic mixture. The polar stationary phase containing precoated silica gel G60 F254 aluminium sheet (10 × 10 cm, 0.2 mm layer thickness) was selected with ethyl acetate‒methanol‒25% ammonia (9:1:1, V/V) as the optimized mobile phase. Very well-resolved peaks of all three drugs were obtained at RF values of 0.23, 0.51, and 0.63 for telmisartan, amlodipine besylate, and bisoprolol fumarate, respectively, at an analytical wavelength of 229 nm. A linear relationship was observed for the concentration range of 1600‒9600 ng/band for telmisartan, 200‒1200 ng/band for amlodipine besylate, and 200‒1200 ng/band for bisoprolol fumarate. The correlation coefficients (r2) for telmisartan, amlodipine besylate and bisoprolol fumarate were found to be 0.996, 0.999, and 0.997, respectively. The method was validated for various parameters as per the International Council for Harmonization (ICH) Q2 (R2) guidelines and was found to be robust, accurate, precise, reproducible, and sensitive for the simultaneous quantification of all three drugs in bulk and in a fixed-dose synthetic mixture.