Development And Validation of RP-HPLC Method For Determination of Valacyclovir by Quality by Design Approach

The term "quality by design" (QbD) refers to the attainment of desired specified requirements with a certain predictable quality. Due to the emphasis on risk assessment and management compared to a traditional or conventional approach, a quality-by-design approach to method development may result in a more robust or rugged method. The L-valy ester prodrug of acyclovir is valacyclovir. Herpes simplex and varicella zoster viruses are both treated with valacyclovir. After being administered orally to healthy adults, valacyclovir is quickly and almost completely transformed into acyclovir. This conversion is assumed to be the outcome of enzymatic hydrolysis during first-pass intestinal and hepatic metabolism. A survey of the literature reveals many analytical methods have been created for valacyclovir, both alone and in combination with other medications. Since there is no QbD-based RP-HPLC method for valacyclovir estimation, the current study covers the creation and validation of a valacyclovir-specific RP-HPLC method. Agilent 1100 series with column (1504.6 mm, 5µm particle size) was used to develop this method. Based on RP-HPLC method development, mobile phase and flow rate were chosen as independent factors and retention time, peak area, theoretical plates, and tailing factor as a response of the drug, which was monitored using design expert 13.0.0.5. By applying CCD, 8 trials with a 2-factor and 4-response method were selected for method development of valacyclovir. The criteria of retention time, peak area, theoretical plates, and tailing factor were used to produce the best approach. According to ICH guidelines, the method was validated for specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification.