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<p>A high-performance thin-layer chromatography (HPTLC) method was developed and validated for the simultaneous quantification of formoterol fumarate (FF) and glycopyrrolate (GP) in pharmaceutical formulations. The method was developed using stationary phase precoated silica gel HPTLC plates 60 F<sub>254</sub> with a mobile phase of toluene–methanol–ethyl acetate–glacial acetic acid (8:2:1:1, <i>V/V</i>). Densitometric scanning was performed at 228&#xa0;nm using a CAMAG TLC Scanner 4. The retardation factors (<i>R</i><sub>F</sub>) were 0.43 for FF and 0.33 for GP, with a resolution of 1.5. Linearity was established over concentration ranges of 400–1400&#xa0;ng/band for FF and 800–2400&#xa0;ng/band for GP, with correlation coefficients (r<sup>2</sup>) of 0.998 and 0.997, respectively. The limit of detection and limit of quantification were 94.85&#xa0;ng/band and 189.65&#xa0;ng/band for FF, and 287.35&#xa0;ng/band and 574&#xa0;ng/band for GP, respectively. Intraday and interday precision showed percentage relative standard deviation (%RSD) values below 2%, indicating high repeatability. Recovery studies at 50%, 100%, and 150% levels yielded 98.5–101.2% for FF and 97.8–100.8% for GP. The method demonstrated specificity with no interference from excipients and robustness via fractional factorial design analysis. The validated method was successfully applied to quantify FF and GP in R/C GLYCOPRESS F powder for inhalation, confirming its suitability for routine quality control.</p>

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High-performance thin-layer chromatography method development and validation for the simultaneous determination of formoterol fumarate and glycopyrrolate in combination inhalation formulations

  • 期刊论文

  • 发表日期：

    2025年12月29日

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  • Jenee R. Christian,
  • Bhanubhai Suhagia,
  • Tejal Soni

摘要

A high-performance thin-layer chromatography (HPTLC) method was developed and validated for the simultaneous quantification of formoterol fumarate (FF) and glycopyrrolate (GP) in pharmaceutical formulations. The method was developed using stationary phase precoated silica gel HPTLC plates 60 F254 with a mobile phase of toluene–methanol–ethyl acetate–glacial acetic acid (8:2:1:1, V/V). Densitometric scanning was performed at 228 nm using a CAMAG TLC Scanner 4. The retardation factors (RF) were 0.43 for FF and 0.33 for GP, with a resolution of 1.5. Linearity was established over concentration ranges of 400–1400 ng/band for FF and 800–2400 ng/band for GP, with correlation coefficients (r2) of 0.998 and 0.997, respectively. The limit of detection and limit of quantification were 94.85 ng/band and 189.65 ng/band for FF, and 287.35 ng/band and 574 ng/band for GP, respectively. Intraday and interday precision showed percentage relative standard deviation (%RSD) values below 2%, indicating high repeatability. Recovery studies at 50%, 100%, and 150% levels yielded 98.5–101.2% for FF and 97.8–100.8% for GP. The method demonstrated specificity with no interference from excipients and robustness via fractional factorial design analysis. The validated method was successfully applied to quantify FF and GP in R/C GLYCOPRESS F powder for inhalation, confirming its suitability for routine quality control.