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<p>An original chemical compound from the class of <i>N</i>-glycosides of indolo[2,3-<i>a</i>]carbazoles, LHS-1269, with significant antitumor activity was synthesized at the N. N. Blokhin National Medical Research Centre of Oncology of the Ministry of Health of the Russian Federation. Its dosage form for injection was obtained. Spectrophotometric and chromatographic methods for quantitative determination of LHS-1269 in the dosage form were developed. A comparative analysis of the validation characteristics showed that both methods were specific, linear, and free from systematic errors, did not differ in precision, and could be used for the assay of LHS-1269 in the dosage form. The HPLC method was preferable, since the detection and quantitation limits of the HPLC method were more than 100 times lower than those of the spectrophotometric method.</p>

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Comparative Analysis of Quantitative Determination Methods of Indolocarbazole Derivative LHS-1269 in Dosage Form

  • 期刊论文

  • 发表日期：

    2025年3月1日

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  • Z. S. Shprakh,
  • E. V. Ignatieva,
  • D. A. Kozin,
  • A. V. Lantsova,
  • L. L. Nikolaeva,
  • D. V. Gusev

摘要

An original chemical compound from the class of N-glycosides of indolo[2,3-a]carbazoles, LHS-1269, with significant antitumor activity was synthesized at the N. N. Blokhin National Medical Research Centre of Oncology of the Ministry of Health of the Russian Federation. Its dosage form for injection was obtained. Spectrophotometric and chromatographic methods for quantitative determination of LHS-1269 in the dosage form were developed. A comparative analysis of the validation characteristics showed that both methods were specific, linear, and free from systematic errors, did not differ in precision, and could be used for the assay of LHS-1269 in the dosage form. The HPLC method was preferable, since the detection and quantitation limits of the HPLC method were more than 100 times lower than those of the spectrophotometric method.