Development and Validation of a Simple Stability-Indicating HPLC Method for the Quantitation of Acyclovir in Pharma-ceuticals and Novel Nanoformulation

Abstract

Acyclovir has been shown to have therapeutic advantages in the management of different viral diseases. Owing to its tremendous and attractive therapeutic applications, a quick, precise, and specific HPLC method was developed and validated in compliance with ICH guidelines. The chromatographic separation was carried out with Column C18 (4.6mm X 250mm), (5 microns) by using 0.1% orthophosphoric acid (OPA) buffer: Methanol (55:45) as mobile phase, with a flow rate of 1 ml/min and at a wavelength of 253 nm. The novel analytical technique showed a peak of acyclovir at 2.4 min. The method was identified to be linear over the concentration ranging from 2 to 14 μg/ml. The method developed was accurate (with 98% recovery), precise, and robust. The developed method was also used for the estimation of acyclovir in various commercial formulations and acyclovir-loaded cubosomal nanoformulation. Furthermore, forced degradation studies for acyclovir were estimated under different stress conditions. In the presence of degradation products, the acyclovir peak was unaffected indicating the suitability of the developed method. Therefore, the developed method could be applied to the estimation of acyclovir in acyclovir-containing formulations.

GRAPHICAL ABSTRACT

Keywords:

• Acyclovir
• HPLC
• Degradation studies
• Marketed product estimation
• Cubosome