A quantitative TLC method was developed for the simultaneous separation and quantification of glimepiride and its main degradation impurities, glimepiride-sulfonamide, and glimepiride-carbamate. Chromatographic analysis was performed using the commercial aluminum-backed TLC plates precoated with silica gel 60F(254) as stationary phase and toluene-ethyl acetate-methanol 8:5:1 (v/v) as the mobile phase. Detection was performed at 230nm. Regression coefficients (r>0.997), recovery (94.9 to 105.1%), determination limit of impurities (7ng spot(-1) equivalent to the 0.1% impurity level), and robustness were validated and found to be satisfactory. The method is convenient for quantitative analysis and purity control of glimepiride in its dosage forms.
Keywords:
glimepiride / hypoglycemic drug / impurities / pharmaceutical dosage forms / quantification / TLC
Source:
Journal of Liquid Chromatography & Related Technologies, 2013, 36, 17, 2422-2430
TY - JOUR
AU - Topić, Valentina
AU - Filipić, Slavica
AU - Popović, Gordana
AU - Nikolić, Katarina
AU - Agbaba, Danica
PY - 2013
UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1968
AB - A quantitative TLC method was developed for the simultaneous separation and quantification of glimepiride and its main degradation impurities, glimepiride-sulfonamide, and glimepiride-carbamate. Chromatographic analysis was performed using the commercial aluminum-backed TLC plates precoated with silica gel 60F(254) as stationary phase and toluene-ethyl acetate-methanol 8:5:1 (v/v) as the mobile phase. Detection was performed at 230nm. Regression coefficients (r>0.997), recovery (94.9 to 105.1%), determination limit of impurities (7ng spot(-1) equivalent to the 0.1% impurity level), and robustness were validated and found to be satisfactory. The method is convenient for quantitative analysis and purity control of glimepiride in its dosage forms.
PB - Taylor & Francis Inc, Philadelphia
T2 - Journal of Liquid Chromatography & Related Technologies
T1 - TLC determination of glimepiride and its main impurities in pharmaceuticals
VL - 36
IS - 17
SP - 2422
EP - 2430
DO - 10.1080/10826076.2013.790767
ER -
@article{
author = "Topić, Valentina and Filipić, Slavica and Popović, Gordana and Nikolić, Katarina and Agbaba, Danica",
year = "2013",
abstract = "A quantitative TLC method was developed for the simultaneous separation and quantification of glimepiride and its main degradation impurities, glimepiride-sulfonamide, and glimepiride-carbamate. Chromatographic analysis was performed using the commercial aluminum-backed TLC plates precoated with silica gel 60F(254) as stationary phase and toluene-ethyl acetate-methanol 8:5:1 (v/v) as the mobile phase. Detection was performed at 230nm. Regression coefficients (r>0.997), recovery (94.9 to 105.1%), determination limit of impurities (7ng spot(-1) equivalent to the 0.1% impurity level), and robustness were validated and found to be satisfactory. The method is convenient for quantitative analysis and purity control of glimepiride in its dosage forms.",
publisher = "Taylor & Francis Inc, Philadelphia",
journal = "Journal of Liquid Chromatography & Related Technologies",
title = "TLC determination of glimepiride and its main impurities in pharmaceuticals",
volume = "36",
number = "17",
pages = "2422-2430",
doi = "10.1080/10826076.2013.790767"
}
Topić, V., Filipić, S., Popović, G., Nikolić, K.,& Agbaba, D.. (2013). TLC determination of glimepiride and its main impurities in pharmaceuticals. in Journal of Liquid Chromatography & Related Technologies
Taylor & Francis Inc, Philadelphia., 36(17), 2422-2430.
https://doi.org/10.1080/10826076.2013.790767
Topić V, Filipić S, Popović G, Nikolić K, Agbaba D. TLC determination of glimepiride and its main impurities in pharmaceuticals. in Journal of Liquid Chromatography & Related Technologies. 2013;36(17):2422-2430.
doi:10.1080/10826076.2013.790767 .
Topić, Valentina, Filipić, Slavica, Popović, Gordana, Nikolić, Katarina, Agbaba, Danica, "TLC determination of glimepiride and its main impurities in pharmaceuticals" in Journal of Liquid Chromatography & Related Technologies, 36, no. 17 (2013):2422-2430,
https://doi.org/10.1080/10826076.2013.790767 . .
