Abstract

DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHOD FOR THE DETERMINATION OF PARTICLE SIZE DISTRIBUTION IN MONTELUKAST USING LASER BASED PARTICLE SIZE ANALYZER (MALVERN 3000)

Ayushman Dash*, Chinmaya Sahoo and Hare Krushna Dash

ABSTRACT

Particle size is a critical quality parameter for pharmaceutical products in which the drug product, a solid dosage form or liquid containing undissolved drug substance. The development of a reliable method for determining particle size distribution is indeed crucial in pharmaceuticals, particularly for drugs like Montelukast Sodium, where bioavailability and dissolution profile are directly influenced by particle size. Study for Particle size is helpful to optimize drug product development process and improve the quality of drugs. The aim of this paper was to develop a new method (dry method) to measure particle size distribution (PSD) of MONTELUKAST SODIUM, by using Malvern Master Sizer 3000. This method is developed and validated as per ICH guidelines (Q2 (R1)) and found out robust and reproducible The %RSD values for different percentile sizes (d(0.1), d(0.5), and d(0.9)) shows that the method developed is highly reliable.

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