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LC methods for acyclovir and related impurities determination.

A L Huidobro¹, F J Rupérez, C Barbas

¹Sección de Química Analítica, Facultad de CC Experimentales y de la Salud, Urbanización Montepríncipe, 28668 Boadilla del Monte, Madrid, Spain.

Journal of Pharmaceutical and Biomedical Analysis

|March 31, 2005

Summary

A new, validated liquid chromatography method effectively separates acyclovir and its key impurities. This reliable method ensures accurate determination of acyclovir and related substances for quality control.

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Area of Science:

Analytical Chemistry
Pharmaceutical Analysis

Background:

Acyclovir is a crucial antiviral medication.
Ensuring the purity of acyclovir is essential for patient safety and drug efficacy.
Pharmacopoeial methods for acyclovir impurity profiling require robust analytical techniques.

Purpose of the Study:

To develop and validate a high-performance liquid chromatography (HPLC) method for the separation and determination of acyclovir and its impurities.
To establish a reliable analytical method for quality control of acyclovir drug substances.

Main Methods:

Utilized a reversed-phase Agilent SB-CN column (150 mm x 4.6 mm, 3.5 µm).
Employed isocratic elution with a mobile phase consisting of 25 mM H3PO4 (pH 3.0 adjusted with KOH) and acetonitrile (96:4, v/v).
Validated the method according to International Council for Harmonisation (ICH) guidelines.

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Main Results:

Achieved baseline separation of acyclovir, guanine, and impurity A within 15 minutes.
Separated acyclovir and six impurities (guanine, A, F, G, Vir 3/4, N(7)) within 40 minutes.
Successfully resolved impurity C, which previously coeluted with acyclovir, by adjusting mobile phase pH to 1.8.

Conclusions:

The developed HPLC method is reliable and suitable for the quantitative determination of acyclovir and its specified impurities.
This validated method enhances the quality control of acyclovir by providing accurate impurity profiling.
The method addresses limitations of previous techniques by achieving separation of all seven pharmacopoeial impurities.