Spectrometric Bioanalytical Method Development and Validation of Tolvaptan in Spiked Human plasma Followed by Forced degradation Studies
Tolvaptan in bulk and formulation in spiking human plasma were estimated using a brand-new, straightforward, speedy, precise, and accurate bioanalytical method that was developed and validated using UV-visible spectrophotometer. The acetonitrile-based solvent chosen for the tolvaptan UV study was sc...
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| Veröffentlicht in: | Research journal of pharmacy and technology 2023-12, Vol.16 (12), p.5996-6001 |
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| creator | Bhavyasri, K. Aishwarya, B. Suchitra, D. Sumakanth, M. |
| description | Tolvaptan in bulk and formulation in spiking human plasma were estimated using a brand-new, straightforward, speedy, precise, and accurate bioanalytical method that was developed and validated using UV-visible spectrophotometer. The acetonitrile-based solvent chosen for the tolvaptan UV study was scanned over the UV spectrum from 200 to 400nm using a solution containing 10g/ml. At 267nm, Tolvaptan exhibits its greatest absorption. The accuracy investigations were conducted at three distinct levels, i.e., 80%, 100%, and 120%, and recovery was found to be in the range of 99.4%. The tolvaptan showed linearity over the range of 5-160g/mL with correlation coefficientnt (r2) of 0.999. The thresholds for detection and quantification were 0.471 and 1.435 g/ml, respectively. In accordance with ICH requirements, all the parameters were validated. |
| doi_str_mv | 10.52711/0974-360X.2023.00973 |
| format | Article |
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The acetonitrile-based solvent chosen for the tolvaptan UV study was scanned over the UV spectrum from 200 to 400nm using a solution containing 10g/ml. At 267nm, Tolvaptan exhibits its greatest absorption. The accuracy investigations were conducted at three distinct levels, i.e., 80%, 100%, and 120%, and recovery was found to be in the range of 99.4%. The tolvaptan showed linearity over the range of 5-160g/mL with correlation coefficientnt (r2) of 0.999. The thresholds for detection and quantification were 0.471 and 1.435 g/ml, respectively. 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| subjects | Accuracy Heart failure Plasma Solvents |
| title | Spectrometric Bioanalytical Method Development and Validation of Tolvaptan in Spiked Human plasma Followed by Forced degradation Studies |
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