Abstract :
Background: A novel, cost-effective infrared spectroscopic method has been developed for the quantitative estimation of hydroxychloroquine sulphate in bulk and tablet dosage forms.
Materials and Methods: The analysis was performed using attenuated total reflectance (ATR) sampling method in FTIR.
Results: The linearity range of the proposed methods were determined to be in the range of 5-45 µg. The percent assay by proposed methods were found to be 100.01±0.0008. Te recoveries from the proposed methods were found to be 99.90 ± 0.008 (by area method) and 100.09 ± 0.007 (by absorption intensity method). The proposed methods were successfully applied for the determination of hydroxychloroquine sulphate in pharmaceutical tablets The proposed methods were validated according to the guidelines set by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Conclusion: The results demonstrated that the proposed methods are accurate, precise, and reproducible (with a relative standard deviation of less than 2 %). Additionally, these methods are simple, cost-effective, and requires less time compared to other available methods. They can be effectively utilized for the estimation of hydroxychloroquine sulphate in various dosage forms.
Keyword :
FTIR, (ATR), (ICH)