Accurate Quantification of Peramivir and its Impurity: A Robust RP-HPLC Method
Ensuring the quality and purity of antiviral drugs through precise analytical techniques.
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1H-1,2,4-Triazole-1-carboximidamide hydrochloride
This article presents a novel and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method specifically developed for the accurate quantification of Peramivir and its significant process-related impurity, 1H-1,2,4-triazole-1-carboximidamide. The method is validated for its application in both bulk drug substances and injectable pharmaceutical formulations, crucial for maintaining the efficacy and safety of antiviral treatments.
- Discover a precise RP-HPLC method for peramivir quantification, ensuring the quality of antiviral medications.
- Analyze the 1H-1,2,4-triazole-1-carboximidamide impurity with high accuracy and reliability in pharmaceutical intermediates.
- Understand the key aspects of peramivir analytical method validation as per ICH guidelines for robust quality control.
- Learn about the application of HPLC in drug impurity analysis for effective pharmaceutical quality control in manufacturing processes.
Key Advantages of the Method
High Precision and Accuracy
The validated RP-HPLC method ensures highly precise and accurate results for both Peramivir and its related impurity, crucial for pharmaceutical quality control.
Robustness and Stability
Demonstrated robustness against variations in flow rate, pH, and column type, alongside solution stability, makes this method reliable for routine use in antiviral drug analysis.
Versatile Application
Applicable to both bulk drug substances and injectable formulations, providing a comprehensive solution for peramivir injectable formulation testing.
Key Applications
Pharmaceutical Intermediate Analysis
Accurately quantifying intermediates like 1H-1,2,4-triazole-1-carboximidamide is vital for the synthesis of antiviral agents.
Antiviral Drug Quality Control
Ensuring the purity and potency of Peramivir through rigorous analytical testing supports the development of effective influenza treatments.
Method Development in Chromatography
This study contributes to the field of chromatography by detailing a validated RP-HPLC method for complex pharmaceutical mixtures.
Regulatory Compliance
Adhering to ICH guidelines for method validation ensures compliance with pharmaceutical industry standards for drug safety and efficacy.