Development and Validation of HPLC method for determination of Methylprednisolone aceponate in cream

Apostolova, Paulina and Karpicarov, Dino and Arev, Marija and Janevik-Ivanovska, Emilija and Gjorgjeska, Biljana and Arsova-Sarafinovska, Zorica (2022) Development and Validation of HPLC method for determination of Methylprednisolone aceponate in cream. Macedonian Pharmaceutical Bulletin.

	Text Trud.pdf Download (163kB)
	Text book of abstract.pdf Download (8MB)

Abstract

Methylprednisolone aceponate (MPA) is an active pharmaceutical ingredient (API), used as a potent topical glucocorticoid that treats various types of eczema and psoriasis. Compared to other glucocorticoids, MPA has high efficiency and reduced application (once a day).
The need to develop and validate a method for routine content determination of MPA in MPA cream, arose due to the lack of individual monograph, both for the active ingredient and for the dosage form, in any of the official and valid editions of different pharmacopoeias.
Therefore, the aim of our study was to develop and validate a simple and rapid reversed-phase HPLC method for the routine determination of MPA in MPA cream. The method performance was fully validated according to the ICH Q2(R1) Guideline by a determination of accuracy, precision, specificity, linearity, and range.
The impact of the system or method changes on the obtained results, was evaluated through the robustness of the method.

Item Type:	Article
Subjects:	Medical and Health Sciences > Basic medicine
Divisions:	Faculty of Medical Science
Depositing User:	Marija Arev
Date Deposited:	22 Jan 2023 17:37
Last Modified:	22 Jan 2023 17:37
URI:	https://eprints.ugd.edu.mk/id/eprint/30820

Actions (login required)

View Item