TLC determination of glimepiride and its main impurities in pharmaceuticals
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.
Keywords:
glimepiride / hypoglycemic drug / impurities / pharmaceutical dosage forms / quantification / TLCSource:
Journal of Liquid Chromatography & Related Technologies, 2013, 36, 17, 2422-2430Publisher:
- Taylor & Francis Inc, Philadelphia
Funding / projects:
Note:
- Peer-reviewed manuscript: http://farfar.pharmacy.bg.ac.rs/handle/123456789/3435
DOI: 10.1080/10826076.2013.790767
ISSN: 1082-6076
WoS: 000321812900008
Scopus: 2-s2.0-84880376950
Collections
Institution/Community
PharmacyTY - 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 . .