New Method for the Estimation and Validation of Fostemsavir and Ganciclovir by using RP-HPLC
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HPLC, Fostemsavir, Ganciclovir, Development, Validation
Abstract
We have evolved a completely unique, reliable HPLC technique for simultaneous quantification of Fostemsavir and Ganciclovir. The chromatographic detachment was attained on an X-Bridge phenyl column (150x4.6mm, 3.5 µ) using isocratic elution with a buffer containing 0.1% OPA and acetonitrile proportion of 50:50 as movable part with a stream of 1 mL/min at room temperature. The maximum absorbance of the drugs was observed at 236 nm. Dissolve 1mL of orthophosphoric acid in 1 lt of HPLC marked water and sieved by using 0.45 µ filter paper, this solution was used as a buffer. 10 min run time was used to separate Fostemsavir and Ganciclovir. Analysis was achieved within 15 min over honest linearity within the concentration range from 6-90 µg/mL of Fostemsavir and 2.5-37.5 µg/mL of Ganciclovir. To check the system suitability parameters, the normal solution was injected six times, from the outcomes, it was concluded that all the outcomes were well under the acceptable range. Precision and recovery study results were well under a suitable range. From this technique, an assay of Fostemsavir and Ganciclovir was performed and the results were well under the acceptable range. Degradation studies were carried out on Fostemsavir and Ganciclovir, with a purity threshold greater than the purity angle in all conditions and within the acceptable range. The above-mentioned technique was validated according to ICH guidelines.
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