Development and validation of an LC-MS/MS method for the determination of adapalene in pharmaceutical forms for skin application
2016
Autori
Dobričić, VladimirBubić-Pajić, Nataša
Marković, Bojan
Vladimirov, Sote
Savić, Snežana
Vuleta, Gordana
Članak u časopisu (Objavljena verzija)
Metapodaci
Prikaz svih podataka o dokumentuApstrakt
The development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of adapalene in pharmaceutical forms for skin application were presented in this study. The MS/MS analysis of adapalene was performed by use of three mobile phases, consisted of acetonitrile and a) 0.1 % formic acid, b) 0.1 % trifluoroacetic acid and c) 20 mM ammonium acetate. The strongest signals of parent ion and dominant product ion were obtained in negative mode by use of the mobile phase c). The validation of this method was performed according to the ICH guidelines. Small variations of selected chromatographic parameters (concentration of ammonium acetate, mobile phase composition, column temperature and flow rate) did not affect significantly the qualitative and quantitative system responses, which proved the method's robustness. The method is specific for the determination of adapalene. The linearity was proved in the concentration range of 6.7-700.0 ng mL...(-1) (r = 0.9990), with limits of detection and quantification of 2.0 and 6.7 ng mL(-1), respectively. The accuracy was confirmed by calculated recoveries (98.4-101.5 %). The precision was tested at three levels: injection repeatability, analysis repeatability and intermediate precision. The calculated relative standard deviations were less than 1, 2 and 3 %, respectively.
Izvor:
Journal of the Serbian Chemical Society, 2016, 81, 10, 1171-1181Izdavač:
- Srpsko hemijsko društvo, Beograd
Finansiranje / projekti:
- Razvoj molekula sa antiinflamatornim i kardioproaktivnim dejstvom: strukturne modifikacije, modelovanje, fizičkohemijska karakterizacija i formulaciona ispitivanja (RS-MESTD-Basic Research (BR or ON)-172041)
DOI: 10.2298/JSC160215066D
ISSN: 0352-5139
WoS: 000388028400007
Scopus: 2-s2.0-84994027727
Institucija/grupa
PharmacyTY - JOUR AU - Dobričić, Vladimir AU - Bubić-Pajić, Nataša AU - Marković, Bojan AU - Vladimirov, Sote AU - Savić, Snežana AU - Vuleta, Gordana PY - 2016 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2627 AB - The development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of adapalene in pharmaceutical forms for skin application were presented in this study. The MS/MS analysis of adapalene was performed by use of three mobile phases, consisted of acetonitrile and a) 0.1 % formic acid, b) 0.1 % trifluoroacetic acid and c) 20 mM ammonium acetate. The strongest signals of parent ion and dominant product ion were obtained in negative mode by use of the mobile phase c). The validation of this method was performed according to the ICH guidelines. Small variations of selected chromatographic parameters (concentration of ammonium acetate, mobile phase composition, column temperature and flow rate) did not affect significantly the qualitative and quantitative system responses, which proved the method's robustness. The method is specific for the determination of adapalene. The linearity was proved in the concentration range of 6.7-700.0 ng mL(-1) (r = 0.9990), with limits of detection and quantification of 2.0 and 6.7 ng mL(-1), respectively. The accuracy was confirmed by calculated recoveries (98.4-101.5 %). The precision was tested at three levels: injection repeatability, analysis repeatability and intermediate precision. The calculated relative standard deviations were less than 1, 2 and 3 %, respectively. PB - Srpsko hemijsko društvo, Beograd T2 - Journal of the Serbian Chemical Society T1 - Development and validation of an LC-MS/MS method for the determination of adapalene in pharmaceutical forms for skin application VL - 81 IS - 10 SP - 1171 EP - 1181 DO - 10.2298/JSC160215066D ER -
@article{ author = "Dobričić, Vladimir and Bubić-Pajić, Nataša and Marković, Bojan and Vladimirov, Sote and Savić, Snežana and Vuleta, Gordana", year = "2016", abstract = "The development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of adapalene in pharmaceutical forms for skin application were presented in this study. The MS/MS analysis of adapalene was performed by use of three mobile phases, consisted of acetonitrile and a) 0.1 % formic acid, b) 0.1 % trifluoroacetic acid and c) 20 mM ammonium acetate. The strongest signals of parent ion and dominant product ion were obtained in negative mode by use of the mobile phase c). The validation of this method was performed according to the ICH guidelines. Small variations of selected chromatographic parameters (concentration of ammonium acetate, mobile phase composition, column temperature and flow rate) did not affect significantly the qualitative and quantitative system responses, which proved the method's robustness. The method is specific for the determination of adapalene. The linearity was proved in the concentration range of 6.7-700.0 ng mL(-1) (r = 0.9990), with limits of detection and quantification of 2.0 and 6.7 ng mL(-1), respectively. The accuracy was confirmed by calculated recoveries (98.4-101.5 %). The precision was tested at three levels: injection repeatability, analysis repeatability and intermediate precision. The calculated relative standard deviations were less than 1, 2 and 3 %, respectively.", publisher = "Srpsko hemijsko društvo, Beograd", journal = "Journal of the Serbian Chemical Society", title = "Development and validation of an LC-MS/MS method for the determination of adapalene in pharmaceutical forms for skin application", volume = "81", number = "10", pages = "1171-1181", doi = "10.2298/JSC160215066D" }
Dobričić, V., Bubić-Pajić, N., Marković, B., Vladimirov, S., Savić, S.,& Vuleta, G.. (2016). Development and validation of an LC-MS/MS method for the determination of adapalene in pharmaceutical forms for skin application. in Journal of the Serbian Chemical Society Srpsko hemijsko društvo, Beograd., 81(10), 1171-1181. https://doi.org/10.2298/JSC160215066D
Dobričić V, Bubić-Pajić N, Marković B, Vladimirov S, Savić S, Vuleta G. Development and validation of an LC-MS/MS method for the determination of adapalene in pharmaceutical forms for skin application. in Journal of the Serbian Chemical Society. 2016;81(10):1171-1181. doi:10.2298/JSC160215066D .
Dobričić, Vladimir, Bubić-Pajić, Nataša, Marković, Bojan, Vladimirov, Sote, Savić, Snežana, Vuleta, Gordana, "Development and validation of an LC-MS/MS method for the determination of adapalene in pharmaceutical forms for skin application" in Journal of the Serbian Chemical Society, 81, no. 10 (2016):1171-1181, https://doi.org/10.2298/JSC160215066D . .