Аннотация:
Scope: the development and validation of the procedure for the quantitative spectrophotometric determination of the active ingredient in the lyophilized liposomal dosage form (LLF-lyo) of the LHS-1208 indolocarbazole derivative. Materials and Methods –The "LHS-1208 liposomal, lyophilizate for the preparation of dispersion for injection 1.8 mg" drug and the LHS-1208 substance. Spectrophotometry. Results –Maxima at 320±2, 286±2, 238±2 and 203±2 nm have been observed in the electronic absorption spectrum (EAS) of the alcohol solution of the LHS-1208 substance in the range from 200 to 800 nm. It has been established that the EAS of an alcoholic solution of liposomal LHS-1208 in the range from 230 to 500 nm is identical to the EAS of an alcohol solution of its substance by the shape of the curve and the position of the maxima. To quantify the LHS-1208 in the LLF-lyo, the most intense absorption band with a maximum of 320±2 nm has been selected. It has been shown that at a wavelength of 320
Ключевые слова:
LHS-1208; Liposomes; Quantitative analysis; Spectrophotometry; Validation
alcohol; carbazole derivative; lhs 1208 indolocarbazole; unclassified drug; absorption spectroscopy; accuracy; analytical parameters; Article; clinical assessment; conceptual framework; drug absorption; drug dosage form; freeze drying; health auxiliary; light absorption; limit of quantitation; linear regression analysis; linearity; liposomal delivery; optical density; probability; quantitative analysis; specificity; spectral sensitivity; spectrophotometry; ultraviolet irradiation; validation process
Dmitrieva M. V. Mariya Vyacheslavovna 0001-
Khashem A. M. Ali Mokhamad 1986-
Ignatyeva E. V. Elena Vladimirovna 0001-
Korol` L. A. Lyudmila Anatolyevna 1959-
Krasnyuk I. I. Ivan Ivanovich 1955-
Dezhurko-Korol` V. A. Viktoriya Andreevna 1991-
Дмитриева М. В. Мария Вячеславовна 0001-
Хашем А. М. Али Мохамад 1986-
Игнатьева Е. В. Елена Владимировна 0001-
Король Л. А. Людмила Анатольевна 1959-
Краснюк И. И. Иван Иванович 1955-
Дежурко-Король В. А. Виктория Андреевна 1991-
Development and validation of the procedure for the quantification of the lyophilized liposomal dosage form of the lhs-1208 indolocarbazole derivative
Текст визуальный непосредственный
Journal of Pharmaceutical Sciences and Research
Vol.10, Issue6 P. 1400-1405
2018
Статья
LHS-1208 Liposomes Quantitative analysis Spectrophotometry Validation
alcohol carbazole derivative lhs 1208 indolocarbazole unclassified drug absorption spectroscopy accuracy analytical parameters Article clinical assessment conceptual framework drug absorption drug dosage form freeze drying health auxiliary light absorption limit of quantitation linear regression analysis linearity liposomal delivery optical density probability quantitative analysis specificity spectral sensitivity spectrophotometry ultraviolet irradiation validation process
Scope: the development and validation of the procedure for the quantitative spectrophotometric determination of the active ingredient in the lyophilized liposomal dosage form (LLF-lyo) of the LHS-1208 indolocarbazole derivative. Materials and Methods –The "LHS-1208 liposomal, lyophilizate for the preparation of dispersion for injection 1.8 mg" drug and the LHS-1208 substance. Spectrophotometry. Results –Maxima at 320±2, 286±2, 238±2 and 203±2 nm have been observed in the electronic absorption spectrum (EAS) of the alcohol solution of the LHS-1208 substance in the range from 200 to 800 nm. It has been established that the EAS of an alcoholic solution of liposomal LHS-1208 in the range from 230 to 500 nm is identical to the EAS of an alcohol solution of its substance by the shape of the curve and the position of the maxima. To quantify the LHS-1208 in the LLF-lyo, the most intense absorption band with a maximum of 320±2 nm has been selected. It has been shown that at a wavelength of 320