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.
Objective: The aim of this work was focused on a simple, rapid, accurate and sensitive method for quantitative analysis of afobazole in microcapsules (afb-m) using high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection.Methods: The analytical procedure was based on the fractionation characteristics of the afobazole in the chromatography column. The chromatography parameters «Zorbax extend-C18» column (150×2.1 mm i.d. 5 µm particle size), at 40 °C. The isocratic mobile phase was 5.0 M ammonium phosphate buffer (pH 7.0): acetonitrile (30:70; v/v) at a flow rate of at 1.0 ml. min-1. The determinations were performed using UV-Vis detector set at 220 nm.Results: An assay procedure for afb-m has been validated from indices, such as specificity, correctness, precision, and linearity. The registered retention time of the afobazole stock solution and the sample solution was 1.5 min. The determined accuracy of the method was in the range of 99.67%-100.67%. The analytical curve was linear (r2-0.9996) over a wide concentration range (50%-150%). The method showed sufficient precision, with a relative standard deviation (RSD) smaller than 2%.Conclusion: The HPLC method developed in this study showed specificity and selectivity with linearity in the working range and good precision and accuracy, making it very suitable for quantification of afb-m. The developed assay procedure of afb-m was meeting all the requirements of ICH validation criteria and can be applied for standardisation drug form afb-m.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.