Development and validation of spectrophotometric quantitative determination of terpene-indole alkaloids (for example, vincristine sulfate and vinblastine sulfate)

Author(s):  O.V. Trineeva, Dr., associate Professor, Voronezh State University, Voronezh, Russia, trineevaov@mail.ru

A. J. Halahakun, Voronezh State University, Voronezh, Russia

A.I. Slivkin , Dr., Prof., Voronezh State University, Voronezh, Russia

Issue:  Volume 41, № 4

Rubric:  Pharmaceutical Sciences

Annotation:  Spectrophotometric methods for the quantitative determination of terpene-indole alkaloids have been developed and validated (using vincristine and vinblastine sulfates as an example). The spectral characteristics of vincristine and vinblastine were studied in the UV region in purified water, methanol, 0.1 M NaOH, 0.1 M HCl, phosphate buffer solution (pH=5), 95 % ethanol, and chloroform in the range 200-320 nm. A pronounced bathochromic shift is observed in the spectra of the studied alkaloids when used as the solvent with the lowest polarity - chloroform. Some hyperchromic effect is observed in the spectra of aqueous and alcoholic solutions of vincristine at 295 nm and vinblastine at 268 nm. Validation of the developed methodology was carried out according to such parameters as specificity, detection limit, limit of quantitative determination, linearity, accuracy, precision and robustness of the analytical method. The presented results can serve as a basis for the development of drafts of pharmacopoeial articles on the pharmaceutical substances of these alkaloids for the State Pharmacopoeia of the Russian Federation. The developed techniques can also be used to determine vincristine and vinblastine sulfates in dosage forms and biological material

Keywords:  vincristine sulfate, vinblastine sulfate, terpene-indole alkaloids, validation, spectrophotometry

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