Development and Validation of an RP‐HPLC Method for the Determination of Valacyclovir in Tablets and Human Serum and Its Application to Drug Dissolution Studies

Abstract

A specific, sensitive, simple, and rapid HPLC method has been developed for the determination of valacyclovir (VACL) in raw material, pharmaceutical dosage forms, and human serum, in order to carry out drug dissolution studies from tablets. The chromatographic separation was achieved with acetonitrile:methanol:0.067 M KH₂PO₄ (27:20:53, v/v/v) adjusted to pH 6.5 with 3 M NaOH as mobile phase, a Waters Spherisorb C18 column, and UV detection at 244 nm. Etodolac was used as an internal standard. Linearity range was 5–20,000 ng mL⁻¹. Limit of detection obtained was 0.38 and 0.14 ng mL⁻¹ in mobile phase and spiked human serum samples, respectively. The described method can be readily applied, without any interferences from the excipients, for the determination of the drug in tablets, human serum samples, and drug dissolution studies.

^#Presented at 11th International Pharmaceutical Technology Symposium, September 9–11, 2002, Istanbul, Turkey.

Keywords:

• Valacyclovir
• HPLC
• Determination
• Pharmaceuticals
• Human serum
• Dissolution profile

Acknowledgments

The authors gratefully acknowledge Glaxo‐Smith‐Kline Pharm. Ind. for supplying valacyclovir standard samples and pharmaceutical preparations.

Notes

^#Presented at 11th International Pharmaceutical Technology Symposium, September 9–11, 2002, Istanbul, Turkey.