Development and Validation of New Analytical Method for the Determination of Particle Size Distribution in Empagliflozin Using Laser-Based Particle Size Analyzer
Jitendra Dubey
*
CTX Lifesciences Pvt. Ltd., Analytical Research and Development, Sachin, Surat, Gujarat 394230, India.
Bakul Rajyaguru
CTX Lifesciences Pvt. Ltd., Analytical Research and Development, Sachin, Surat, Gujarat 394230, India.
Kushal Vankawala
CTX Lifesciences Pvt. Ltd., Analytical Research and Development, Sachin, Surat, Gujarat 394230, India.
Frenil Vaidya
CTX Lifesciences Pvt. Ltd., Analytical Research and Development, Sachin, Surat, Gujarat 394230, India.
Jeelkumari Mistri
CTX Lifesciences Pvt. Ltd., Analytical Research and Development, Sachin, Surat, Gujarat 394230, India.
Kishan Surati
CTX Lifesciences Pvt. Ltd., Analytical Research and Development, Sachin, Surat, Gujarat 394230, India.
*Author to whom correspondence should be addressed.
Abstract
This paper describes a rugged and precise analytical method developed and validated for determining the particle size distribution of Empagliflozin drug substance using a wet dispersion technique on the Malvern Mastersizer 3000. The method was optimized to achieve uniform dispersion and reproducible measurements of particle size parameters (D10, D50, D90). Validation of the method was carried out in accordance with ICH Q2(R2) guideline and demonstrated satisfactory results for precision, intermediate precision, and robustness. All validation parameters were found within the predefined acceptance criteria, confirming the reliability of the procedure. Hence, the developed method is suitable for particle size analysis of Empagliflozin active pharmaceutical ingredient (API).
Keywords: Empagliflozin, drug subatance, Active Pharmaceutical Ingredient (API), particle size distribution, wet dispersion, Malvern Mastersizer 3000, method validation, robustness