Abstract

QBD APPROACH IN HPLC METHOD DEVELOPMENT AND VALIDATION OF LETROZOLE

Vishnu Kailasbhai Patil, Shabnam Khan*, Jeevan Patel, Ramakant Sharma, Dr. Rakesh Patel

ABSTRACT

The present study, in a nutshell, demonstrated the successful application of QbD principles for establishment of a HPLC method for Letrozole with improved robustness and performance. On the basis of the initial prioritization and factor screening studies, the highly influential factors were identified and subsequently optimized for improving the method robustness. The response surface mapping particularly facilitated improved understanding of the factor–response relationship and interactions associated with them. Extensive validation studies further ensured high degree of method robustness with extreme variation in the key variables influencing the method performance. In addition, the method showed improved sensitivity for the Letrozole much beyond the values reported in the literature. A simple, rapid, sensitive and economic stability-indicating analytical method has been successfully developed employing the systematic QbD-based approach for quantification of Letrozole. Application of risk assessment studies helped in prioritizing the factors, critically influencing the method parameters.

Keywords: QbD Approach, HPLC Method Development, Validation, Letrozole”