Volume 20 No 13 (2022)
Download PDF
Development, Validation and Forced Degradation Study of Beclomethason Dipropionate in Bulk and Pharmaceutical Dosage Form by HPTLC Method
BavkarManasiM, Ganesh S Andhale, Madhuri Shelar, Jyoti N Kadam, Sonia Singh, Sapana Nagare
Abstract
Objective:-The Present work describes the development and validation of a new simple, accurate, precise
and stability-indicating HPTLC method for the determination of Beclomethason Dipropionate in the capsule
dosage form. Methods:-The chromatographic separation was achieved by using Ethyl acetate: Toluene:
Formic acid (4:6:0.2 v/v/v) as mobile phase and UV detection at 252nm with Rf value 0.64. This developed
method was validated based on linearity, accuracy, precision, the limit of detection, the limit of quantitation
and robustness as per ICH guidelines. Result:-The described method was linear over a concentration range
of 200-1000 ng/band with correlation coefficient (r2)> 0.9995. The recovery was found to be 98.14%. The
limit of detection (LOD) and the limit of quantification (LOQ) for Beclomethason was found to be 28.30
ng/band and 85.76 ng/band respectively. The drug was shows a stress conditions of acid hydrolysis, alkali
hydrolysis, photolysis, thermal degradation.Conclusion:-The proposed stabilityindicating method can be
used for the determination of Beclomethason Dipropionate in bulk samples and in the pharmaceutical
dosage form
Keywords
Hydrolysis, ICH guideline, Mobile phase, TLC Plate
Copyright
Copyright © Neuroquantology
Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Articles published in the Neuroquantology are available under Creative Commons Attribution Non-Commercial No Derivatives Licence (CC BY-NC-ND 4.0). Authors retain copyright in their work and grant IJECSE right of first publication under CC BY-NC-ND 4.0. Users have the right to read, download, copy, distribute, print, search, or link to the full texts of articles in this journal, and to use them for any other lawful purpose.