Development and Validation of Novel Analytical Method for the Determination of Particle Size Distribution in Ciprofloxacin Hydrochloride Using Laser-based Particle Size Analyzer
Amit Gosar
Indoco Remedies Limited, R and D Centre Rabale, Navi Mumbai, Maharashtra-400701, India.
Chetana Parange
Indoco Remedies Limited, R and D Centre Rabale, Navi Mumbai, Maharashtra-400701, India.
Suyog Narvankar
Indoco Remedies Limited, R and D Centre Rabale, Navi Mumbai, Maharashtra-400701, India.
Shivaji Jadhav *
Indoco Remedies Limited, R and D Centre Rabale, Navi Mumbai, Maharashtra-400701, India.
Vikram Patil
Indoco Remedies Limited, R and D Centre Rabale, Navi Mumbai, Maharashtra-400701, India.
*Author to whom correspondence should be addressed.
Abstract
This paper described a rugged and precise particle size determination method that has been developed and validated for the determination of particle size distribution of Ciprofloxacin Hydrochloride by a dry method using Malvern Mastersizer 2000.
The Method of the particle size distribution of Ciprofloxacin Hydrochloride was precisely developed and validated successfully. By using parameters like Precision, Intermediate precision, and Robustness the method was validated. All the particle size data has been compiled and found to be satisfactory, Hence the method is suitably used for the analysis of the Particle size analyzer of Ciprofloxacin Hydrochloride active pharmaceutical ingredients.
Keywords: Ciprofloxacin hydrochloride, method validation, Particle Size Analyzer (PSA)