Development and Validation of Analytical HPLC Method for Identification and Assay of Enoxaparin Sodium in Injectable Preparations

Abstract

Introduction. Enoxaparin sodium-containing drugs are included in relevant protocols for COVID-19 therapy. An increase in the production volume of such drugs leads to a demand for available and precise methods of identification and quantitative measurement of the active ingredient in the preparations. Considering the fact that pharmacopoeial methods require significant amount of expensive standards and reagents that are unavailable for numerous laboratories, it is relevant to develop a more available method that will accelerate and make cheaper the process of quality control for enoxaparin sodium-containing preparations.Aim. To develop and validate a simple, economic, and precise method of gel-permeation HPLC with the application of a refractive index detector for the evaluation of enoxaparin sodium in preparations for injection.Materials and methods. Samples of enoxaparin sodium-containing substances and commercial preparations were studied. The identification and quantitative content of the active ingredient were performed by the method of gel-permeation HPLC using a 1260 Infinity (Agilent Technologies, USA) chromatograph equipped with a refractive index detector.Results and discussion. The authors analyzed standard validation characteristics: specificity, linearity, precision, and accuracy of the method. The analysis revealed high specificity and suitability of the proposed method to chromatographic symmetrical multiprocessing systems. The method is recommended for routine control of finished and semi-finished pharmaceutical preparations containing from 25 to 200 mg/ml of enoxaparin sodium-containing.Conclusion. The proposed method can be used for routine quality control of enoxaparin sodium-containing preparations for injection.