The present study describes the steps to take and the results of an HPTLC approach that is simple, sensitive, specific, and stable that may be used to quantify the GnRH receptor antagonist Relugolix, which is used to treat prostate cancer. The desired separation was accomplished by using a mobile phase consisting of acetonitrile, methanol, and orthophosphoric acid in a ratio of 6:3:1, v/v/v, on silica gel 60 F2?4 aluminum plates. An Rf value of 0.45 ± 0.02 was obtained from the densitometric detection at 254 nm, where Relugolix showed a clear and well separated peak. An outstanding linear response was shown by a correlation coefficient (R²) of 0.998, which was determined to be linear throughout the concentration range of 100-500 ng/spot. With an intra-day and inter-day %RSD < 1%, the method demonstrated excellent accuracy, and recovery rates ranged from 99.28% to 99.38%. We found that the limit of detection (LOD) is 18 µL and the limit of quantification (LOQ) is 84 µL, indicating that it is very sensitive. There was no interference from excipients, as shown by specificity testing, and consistent performance was shown by robustness tests when subjected to small variations in chromatographic settings. This HPTLC technique is a reliable option for regular quality control, stability testing, and quantitative estimate of Relugolix in bulk medication and pharmaceutical dosage forms since it meets all the validation standards outlined in the ICH Q2(R1) recommendations.
Relugolix, HPTLC, Method Validation, Linearity, Pharmaceutical Analysis.
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