Issue 33, 2021

Development and validation of a RP-UPLC method for the determination of betamethasone dipropionate impurities in topical formulations using a multivariate central composite design

Abstract

The current study presents a specific, accurate, simple, and rapid UPLC method for the determination of impurities present in cream and ointment formulations of betamethasone dipropionate (BMD). The analytical method was optimized using central composite design (CCD) prior to the method validation. Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) were identified for the analytical method. A total of 17 experiments were carried out and verified the individual and interaction effects of CPPs. The CPPs were optimized using a numerical method by keeping the CQAs within the desired range (R1–R2: minimize & R3–R5: maximize) as an optimization goal. Optimized chromatographic separation was achieved using a Waters Acquity UPLC BEH C18, 100 mm × 2.1 mm, 1.7 μm column with a gradient mode of elution comprising 20 mM phosphate buffer: ACN 70 : 30, v/v as mobile phase-A and 20 mM phosphate buffer: ACN 30 : 70, v/v as mobile phase-B. The developed method was validated in accordance with ICH guidelines. The validation data conclude that the developed method is specific, accurate, linear, precise, rugged, and robust for the quantification of impurities in BMD topical formulations.

Graphical abstract: Development and validation of a RP-UPLC method for the determination of betamethasone dipropionate impurities in topical formulations using a multivariate central composite design

Article information

Article type
Paper
Submitted
26 Jun 2021
Accepted
09 Jul 2021
First published
09 Jul 2021

Anal. Methods, 2021,13, 3705-3723

Development and validation of a RP-UPLC method for the determination of betamethasone dipropionate impurities in topical formulations using a multivariate central composite design

S. K. Muchakayala, K. Pavithra, N. K. Katari, V. M. Marisetti, T. Dongala and R. V. K. Vegesna, Anal. Methods, 2021, 13, 3705 DOI: 10.1039/D1AY01096D

To request permission to reproduce material from this article, please go to the Copyright Clearance Center request page.

If you are an author contributing to an RSC publication, you do not need to request permission provided correct acknowledgement is given.

If you are the author of this article, you do not need to request permission to reproduce figures and diagrams provided correct acknowledgement is given. If you want to reproduce the whole article in a third-party publication (excluding your thesis/dissertation for which permission is not required) please go to the Copyright Clearance Center request page.

Read more about how to correctly acknowledge RSC content.

Social activity

Spotlight

Advertisements