Stability-Indicating Method Development and Validation for Quantitative Estimation of Assay and Organic Impurities of anti-viral drug Baloxavir-Marboxil in Drug Substance and Pharmaceutical Dosage Form using HPLC and LC-MS Methods

Baloxavir-Marboxil (BXM) is a polymerase-acidic-endonuclease inhibitor used as an anti-viral drug. A simple, reliable, and robust liquid chromatographic method was developed and validated per ICH Q2(R1) for estimating the assay and impurities of BXM in drug substance and pharmaceutical formulations. The chromatographic separation was carried-out on C18 (100 x 4.6 mm, 5-μm) with binary solvent delivery system (A:0.1% trifluoroacetic-acid in water; B:0.1% trifluoroacetic-acid in acetonitrile) along with detection wavelength of 260 nm, column temperature of 57°C, flow of 1.2-mL/min and injection volume of 10-μL. All five known impurities and unknown impurities were separated well with resolution >1.7, and were estimated accurately without any interference. Recovered values and regression value were 99.5-101.2% and R2 >0.999, respectively. The recovery and linearity studies covered from 50-150% for assay, and quantitation limit (QL) - 120% for five BXM impurities. Stability-indicating property of the HPLC developed method was assessed from the forced degradation studies. The mass spectral data of unknown impurity formed under oxidation stress condition was discussed. The developed method was also successfully utilized for stability samples analysis of drug substance and tablets dosage form.

 

Comments：

It seems that you are presenting information about the development and validation of a liquid chromatographic method for the estimation of assay and impurities of Baloxavir-Marboxil (BXM) in drug substance and pharmaceutical formulations. The method uses a C18 column with a binary solvent delivery system and a detection wavelength of 260 nm. The developed method is reliable, robust, and meets the International Conference on Harmonisation (ICH) Q2(R1) guidelines for validation.

The method is capable of separating and accurately estimating all five known impurities and unknown impurities in BXM without any interference. The recovery and linearity studies cover a wide range of concentrations, and the method's quantitation limit is up to 120% for five BXM impurities. The HPLC developed method's stability-indicating property is assessed through forced degradation studies, which showed that it is suitable for stability samples analysis of drug substance and tablets dosage form.

Overall, the information provided suggests that the developed method is effective and can be utilized for the accurate and reliable estimation of BXM's assay and impurities in drug substance and pharmaceutical formulations.

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Cat.No.	Product Name	Information
S5952	Baloxavir marboxil	Baloxavir marboxil(S-033188), a cap-endonuclease inhibitor, is an antiviral drug.

Related Targets

Antiviral