A Novel Validated Uhplc Method For Estimation Of Assay And Its Related Substances Of Trichostatin-A
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Date
2020-07
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Publisher
Innovare Academic Sciences Pvt. Ltd.
Abstract
Objective: The main objective of the research work is to develop and validate a rapid UHPLC method for the estimation of assay and its related substances of Trichostatin A (TSA) in pharmaceutical samples.
Methods: The UHPLC method developed for chromatographic separation between TSA and its related compounds on Poroshell 120 SB C18(50×4.6) mm; 2.7 µm RRLC column using Agilent RRLC (UHPLC) system with linear gradient elution.
Results: The developed UHPLC method has shown excellent chromatographic separation between TSA and its related compounds within 12 min run time, during validation experiments, specificity study revealed that the peak threshold was more than the peak purity and no purity flag was observed. Repeatability, intra, and inter-day precision results were well within the tolerable limits. Limits of detection concentrations were found between 0.075 to 0.077 ppm and the limit of quantitation is between 0.252 to 0.258 ppm for related compounds and TSA. The related substances method recoveries were found between 80 and 120 % and assay method recovery was found between 98.0 to 102.0%.
Conclusion: The developed method capability was proven for the assay of TSA and its related compounds in pharmaceutical samples and the method shows eco-friendlier than routine, conventional HPLC methods in terms of analysis time, cost and HPLC effluent waste.
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Keywords
Trichostatin A, Assay, Related substances, Method Validation, RRLC, UHPLC
Citation
Rao L. V., Rao K. T., Kandepi V. V. K. M. . A Novel Validated Uhplc Method For Estimation Of Assay And Its Related Substances Of Trichostatin-A. International Journal of Pharmacy and Pharmaceutical Sciences. 2020 Jul; 12(7): 45-50