Development and validation of HPLC method for content determination of Meloxicam in injections

Karpicarov, Dino and Apostolova, Paulina and Arev, Marija and Arsova-Sarafinovska, Zorica and Gjorgjeska, Biljana (2023) Development and validation of HPLC method for content determination of Meloxicam in injections. Knowledge - International Journal, 57 (4). pp. 517-522. ISSN 2545-4439

	Text DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR CONTENT DETERMINATION OF MELOXICAM IN INJECTIONS.pdf - Published Version Download (804kB)
	Text Programa.pdf Download (319kB)
	Text Sokobanja 2023.pdf Download (365kB)

Abstract

The principal aim of this paper is to establish and validate a rapid, simple, and economical approach that employs high-pressure liquid chromatography, capable of routinely assessing the content of Meloxicam present in injections. To accomplish this goal, it is necessary to meet the requirements outlined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, as well as the specifications delineated in the contemporary editions of the internationally recognized pharmacopeias that pertain to the design and validation of analytical methodologies. The analytical methodology was performed with the utilization of a high-performance liquid chromatography system, Waters Alliance (Waters corporation, USA), consisting of a quadrupole pump, an e-2695 separation module, and an automatic sampler. The optimization of the detection wavelength was accomplished using the Waters 2489 UV/Vis detector and Empower 3 software was employed for data processing. Separation was achieved via the deployment of a LiChrospher 100, RP-18 (5 μm) column. The mobile phase used in the study consisted of a combination of Acetonitrile and ultrapure water, in a 60:40 ratio, respectively. The pH of the water component was subsequently adjusted to 3.1 with the addition of glacial acetic acid. This reversed-phase column approach, using an isocratic method, was then utilized for the successful validation of the analytical method. According to the obtained results, the developed analytical method exhibits accuracy and precision under consistent conditions over a limited period and on a single sample, as well as precision when conducted in the same laboratory on the same day by two analysts. Furthermore, the method is specific, linear across the range, and robust against variations in the ratio of the mobile phase components, the pH of the water in the mobile phase, and the flow rate. These findings support the utility and reliability of the developed methodology for the routine determination of Meloxicam content in injections. In conclusion, the reversed-phase column approach using an isocratic method proved to be a successful and robust analytical method for the determination of Meloxicam content in injections. This fast, simple, and cost-effective alternative offers a promising solution for the analysis of other related drugs with similar chemical properties. Furthermore, the simplicity and ease of application of this method offer significant advantages, as it does not require any special preparation of the working environment or prior training of the analyst. Thus, this method represents a valuable contribution to the field of pharmaceutical analysis, and it may facilitate the quality control of Meloxicam-containing products. Overall, this study provides a foundation for further development and optimization of analytical methods for the analysis of other drugs with similar properties, leading to better quality control and improved patient safety.

Item Type:	Article
Subjects:	Medical and Health Sciences > Other medical sciences
Divisions:	Faculty of Medical Science
Depositing User:	Dino Karpicarov
Date Deposited:	24 Apr 2023 12:25
Last Modified:	28 Apr 2023 07:17
URI:	https://eprints.ugd.edu.mk/id/eprint/31666

Actions (login required)

View Item