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VALIDATED SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF VINCRISTINE AND VINBLASTINE
摘要: Objective: A simple, sensitive, precise, reproducible and validated UV spectrophotometric methods have been developed for the determination of vincristine (VCR) and vinblastine (VLB) in the pure and dosage forms. Methods: The method was founded on the simple solubility of VCR and VLB in purified water, and their characteristic maximum absorption λ (max) at 295 nm and λ (max) at 268 nm for VCR and VLB respectively in the UV regions. The nature of obedience, to the Bouguer-Lambert-Beer’s law by the VCR and VLB in the range of concentration 5-50 μg/ml was employed to this method. Results: Accuracy and reproducibility of the proposed method were statistically validated by recovery studies. The accuracy of the method for the VCR and VLB was ~ 100.4 % and ~ 100.32 % respectively with good reproducibility. The analytical curves were linear over a wide concentration range (5-50 μg/ml), with a correlation coefficient (r)-0.9998, and 0.9999 for VCR and VLB in that order. The method was showed sufficient precision, with a relative standard deviation (RSD) less than 1%. Conclusion: The method was validated in accordance with Russian general pharmacopoeia article (RGPA) 42-0113-09 and ICH guidelines. Validated method can easily apply for fast, precise and reliable rapid assessment of drug forms and pure substances in the laboratory.
关键词: Vincristine,Quantity determination,Analytical curve,Vinblastine,UV-visible spectrometry
更新于2025-09-23 15:22:29