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Sci. Pharm. 2014, 82(3), 617-630; doi:10.3797/scipharm.1403-20

An Experimental Design Approach for Impurity Profiling of Valacyclovir-Related Products by RP-HPLC

1
Faculty of Pharmacy, University of Zawia, Az Zawiyah, Libya
2
School of Medical Science & Technology, IIT Kharaghpur, India
3
Division of Biotechnology, Netaji Subhas Institute of Technology, New Delhi, India
*
Author to whom correspondence should be addressed.
Received: 24 March 2014 / Accepted: 5 May 2014 / Published: 5 May 2014
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Abstract

Impurity profiling has become an important phase of pharmaceutical research where both spectroscopic and chromatographic methods find applications. The analytical methodology needs to be very sensitive, specific, and precise which will separate and determine the impurity of interest at the 0.1% level. Current research reports a validated RP-HPLC method to detect and separate valacyclovir-related impurities (Imp-E and Imp-G) using the Box-Behnken design approach of response surface methodology. A gradient mobile phase (buffer: acetonitrile as mobile phase A and acetonitrile: methanol as mobile phase B) was used. Linearity was found in the concentration range of 50–150 μg/mL. The mean recovery of impurities was 99.9% and 103.2%, respectively. The %RSD for the peak areas of Imp-E and Imp-G were 0.9 and 0.1, respectively. No blank interferences at the retention times of the impurities suggest the specificity of the method. The LOD values were 0.0024 μg/mL for Imp-E and 0.04 μg/mL for Imp-G and the LOQ values were obtained as 0.0082 μg/mL and 0.136 μg/mL, respectively, for the impurities. The S/N ratios in both cases were within the specification limits. Proper peak shapes and satisfactory resolution with good retention times suggested the suitability of the method for impurity profiling of valacyclovir-related drug substances.
Keywords: Impurity profiling; Box-Behnken design; Retention time; Validated method; Response Surface Methodology; Valaciclovir Impurity profiling; Box-Behnken design; Retention time; Validated method; Response Surface Methodology; Valaciclovir
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

KATAKAM, P.; DEY, B.; HWISA, N.T.; ASSALEH, F.H.; CHANDU, B.R.; SINGLA, R.K.; MITRA, A. An Experimental Design Approach for Impurity Profiling of Valacyclovir-Related Products by RP-HPLC. Sci. Pharm. 2014, 82, 617-630.

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