Abstract

DEVELOPMENT AND VALIDATION OF NOVEL ANALYTICAL METHOD FOR THE DETERMINATION OF PARTICLE SIZE DISTRIBUTION IN LUMEFANTRINE USING LASER-BASED PARTICLE SIZE ANALYZER

Amit Gosar, Shivaji Jadhav, Amit Lalge and Mahesh Patil*

.

Abstract

The particle size distribution of Lumefantrine method development and subsequently validation was carried out by using the Malvern Instrument equipped with laser diffraction techniques. The method was developed by optimizing the instrumental parameter along with the optical parameter. Particle size is the key factor for modern drug quality since it affects the bioavailability and dissolution profile of the drug product. A study on Particle size is helpful to optimize the drug product development process and improve the quality of drugs. An Innovative and precise Particle size determination method has been developed for the determination of particle size distribution of Lumefantrine was described in this paper. This method has shown good reproducible results. By using water as a dispersant wet method is developed. Validation is performed as per the International Conference on Harmonization guidelines (Q2 (R1) and found robust and reproducible with % RSD of d (10), d (50), and d (90) values found within the acceptable limit invalidation. The described method is precisely developed and validated successfully and applied for the determination of particle size distribution of Lumefantrine. The particle size method is discussed in detail to ensure an in-depth understanding of particle size distribution and said method can be used for particle size determination of Lumefantrine. The method was validated for Precision, Intermediate Precision, and Robustness.

Keywords: Lumefantrine, Method Development, Method Validation, and Particle size analyzer (PSA).