Abstract
To establish a simple, sensitive, as well as specified method for the separation and quantitative determination of glyoxylic acid in emtricitabine by using reversed-phase high-performance liquid chromatography (RP-HPLC). A superior separation of glyoxylic acid in emtricitabine was done by using a C8 column and a mobile system of (0.1% OPA and ACN: H2O) with 1-mL/min flow rate in gradient mode and a wavelength of 210 nm. The glyoxylic acid was eluted at 5.37 minutes with good efficiency and system suitability. The method has shown good linearity ranges from a limit of detection (LoQ) to 150% level of glyoxylic acid standard solution (0.1% or 0.001 mg/mL). ICH principles validated the suggested approach, and every parameter met the requirements for the International Council of Harmonization (ICH) Q2 recognition. %RSD of System, method precision, and precision at LoQ were in the range of 0.46 to 1.91. The developed method was sensitive, specific, and precise in estimating the trace levels of glyoxylic acid in emtricitabine.
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