Analytical Quality by Design (QbD) Approach to RP-HPLC Method Development and Validation of Meloxicam
Anup A. Puranpole*, Vijayalaxmi A. Chavan, Priyanka Kodrikar, Ganesh Mali
Quality by Design (QbD) refers to a holistic approach towards drug development. Meloxicam is a Non steroidal anti-inflammatory drug (NSAID) which acts by inhibition of prostaglandin synthetase (cyclooxygenase 1 and 2) leading to the inhibition of prostaglandin synthesis, thereby exerts anti-inflammatory, antipyretic and analgesic effects. Though, various analytical methods have been reported, but they are tedious, difficult to reproduce and time consuming. So there is need to develop a novel RP-HPLC method to overcome this problem. A simple, fast and robust HPLC analytical method was developed by employing experimental design. In experimental design, Analysis of variance (ANOVA) was performed to study the significance of the method critical factors such as % composition of mobile phase, flow rate and wavelength on the response (asymmetric factor) was tested. The Reverse Phase (RP) HPLC method was successfully developed and validated according to International Conference of Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, robustness, LOD, LOQ. The polynomial regression data for the calibration plots exhibited linear relationship (r2 = 0.999) over a concentration range of 25–125μg/ml and the linear regression equation was y = 41905x – 53177. The % coefficient of variation for both intra-day and inter-day precision was less than 2%. The good recoveries of MLX were obtained as more than 99%. The proposed method has proven that method is accurate, precise, reproducible and suitable for regulatory flexibility.
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