Development and Validation of New Analytical Method for the Determination of Particle Size Distribution in Empagliflozin Using Laser-Based Particle Size Analyzer
Jitendra Dubey, Bakul Rajyaguru, Kushal Vankawala, Frenil Vaidya, Jeelkumari Mistri, Kishan Surati
Journal of Advances in Medical and Pharmaceutical Sciences · pp. 65–74 · Published 7 Nov 2025
10.9734/jamps/2025/v27i11828Abstract
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).
Cited by 1
1 citation reported by external sources — individual citing-article records aren't available to list yet.
Related research
- Evaluation of Effective and Safe Extraction Method for Analysis of Polycyclic Aromatic Hydrocarbons in Kolanuts from Côte d’Ivoire — shares topic coverage
- Dissipation Dynamics and Risk Assessment of Imidacloprid in Grape Berries Using LC- MS for Food Safety — shares topic coverage
- Development and Validation of New Analytical Method for the Determination of Particle Size Distribution of Metformin Hydrochloride Using Laser Based Particle Size Analyzer — shares topic coverage
- Development and Validation of Bio Analytical Method for Estimation of Bortezomib in k3 EDTA Human Plasma Using HPLC-ESI-MS/MS and Its Application to a Bioequivalence & CME Studies — shares topic coverage
- Studies on the Persistence of Pyraclostrobin 10% CS in Acidic, Neutral and Basic Waters by Validated HPLC-DAD Method — shares topic coverage
Article metrics
Real usage data collected on this platform.
0
Page views
0
PDF downloads
0
Outbound clicks
1
Citations
Views by country
Approximate, from request IP at view time — not citizenship or institution. Countries with fewer than 5 views are grouped as "Other".
No views recorded yet.
Traffic sources
Referring site, by host.
No traffic recorded yet.
Views and downloads exclude known bots/crawlers. Citations combines this platform's own DOI-resolved index with each external source's own reported total — see Cited by above for individually listed citing works. Last refreshed 0 seconds ago.