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.
Highlights
The high-performance liquid chromatography (HPLC) method is an analytical method in which proving the separation-related impurities and its drug compound, and it helps to estimate the content of impurities and drugs to prove the quality of the drug substances [1,2,3]
The ultra-high performance liquid chromatographic method (UHPLC) method [4] has developed for the chromatographic separation between Trichostatin A (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 and the developed method was validated as per stated guidelines [21, 24] to meet the suitability of the method and method development efforts, the outcome of validation experimental results are described in results and discussion section
The chromatographic separation was achieved on Poroshell SBC18 UHPLC/RRLC column (50×4.6 mm; 2.7 μm) using mobile phase A as 0.1% v/v orthophosphoric acid and mobile phase B as acetonitrile with a linear gradient program: time/% B is 0/10, 7/65, 8/10, and 12/40 at a flow rate of 0.6 ml/min and the column temperature was maintained at 25 °C using 5.0 μl injection volume
Summary
The HPLC method is an analytical method in which proving the separation-related impurities and its drug compound, and it helps to estimate the content of impurities and drugs to prove the quality of the drug substances [1,2,3]. Various UHPLC methods have been developed for the determination of related compounds and potency of the drug in pharmaceutical drug substances and formulations and many bioanalytical methods were developed to estimate the drug content in the pharmacy kinetic study and dietary samples [7,8,9,10]. TSA serves as an antifungal antibiotic and selectively inhibits the class I and II mammalian histone deacetylase (HDAC) families of enzymes, but not class III HDACs (i.e., sirtuins) [11, 12]. It is a member of a larger class of histone deacetylase inhibitors (HDIs or HDACIs) that have a broad spectrum of epigenetic activities. TSA has some potential as an anti-cancer drug [13, 14]
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