Determination of Fenspiride Hydrochloride Residues on Pharmaceutical Manufacturing Equipment Surfaces by HPLC Method
Тип публікації :
Стаття
Дата випуску :
2018
Автор(и) :
Fedosenko, Ganna
Yegorova, Alla
Scrypynets, Yulia
Leonenko, Inna
Vitukova, Ekaterina
Мова основного тексту :
Англійська
eKNUTSHIR URL :
Том :
6
Випуск :
1
ISSN :
2312-3222
Початкова сторінка :
7
Кінцева сторінка :
15
Цитування :
[APA 7] Fedosenko, G., Yegorova, A., Scrypynets, Y., Leonenko, I., & Vitukova, E. (2018). Determination of Fenspiride Hydrochloride Residues on Pharmaceutical Manufacturing Equipment Surfaces by HPLC Method. French-Ukrainian Journal of Chemistry, 6(1), 7–15. https://doi.org/10.17721/fujcV6I1P7-15
[ДСТУ] Determination of Fenspiride Hydrochloride Residues on Pharmaceutical Manufacturing Equipment Surfaces by HPLC Method / G. Fedosenko et al. French-Ukrainian Journal of Chemistry. 2018. Vol. 6, no. 1. P. 7—15. DOI: 10.17721/fujcV6I1P7-15 (date of access: 25.07.2026).
The cleaning procedure must be validated, so special attention must be devoted to the methods used for determination of trace amounts of drugs. A rapid, sensitive, and specific reverse phase high-performance liquid chromatographic (HPLC) method was developed for the quantitative determination of fenspiride hydrochloride residues on pharmaceutical manufacturing equipment surfaces. The calibration curve was linear over a concentration range from 1.0 to 100.0 μg/ml with a correlation coefficient of 0.99994. The detection limit and quantitation limit were 0.41 μg/ml and 1.25 μg/ml, respectively. The developed method was validated with respect to specificity, linearity, limit of detection, accuracy and precision.
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