DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ANALYSIS OF NOVEL NITROIMIDAZOOXAZINE ANTIMYCOBACTERIAL DRUG PRETOMANID

The medication pretomanid effectively treats drug-resistant tuberculosis (MDR TB). For the analysis of pretomanid, a simple, focused, and accurate HPTLC method has been created and approved. The samples were applied as bands on a silica gel-coated TLC plate made of aluminium. Pretomanid was completely separated using ethyl acetate and n-hexane as the mobile phase; the RF value was 0.68 0.046. Densitometry was used for detection, namely in absorbance mode at 330 nm. The peaks produced by this approach were discovered to be crisp, symmetrical, and highly resolved. A linear relationship was found across the concentration range of 200-1200ng/spot with coefficients of determination of 0.987. According to the International Conference on Harmonization’s criteria, the method’s accuracy, recovery, repeatability, and robustness were all confirmed. The limit of quantitation was determined to be 439.36 ng/spot, while the lowest detectable level was found to be 144.9 ng/spot. According to statistical analysis of the data, the procedure is exact, accurate, repeatable, and selective for the examination of Pretomanid. The suggested single approach permitted analysis of Pretomanid in the presence of their degradation products created under various stress conditions, according to the findings of the validation research. The established method might be used to assess Pretomanid’s stability in commercial pharmaceutical dosage form. Regarding the HPTLC-based Pretomanid degrading behaviour, no prior technique has been documented. Pretomanid was successfully estimated and quantified using the technique in a commercially available preparation.