DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING METHOD FOR ASSAY OF SUGAMMADEX SODIUM INJECTION BY RP HPLC METHOD

Abstract

A robust, specific, and stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantification of Sugammadex in Sugammadex sodium injection. Chromatographic separation was achieved using a Kinetex C18 100Å column (150 × 4.6 mm, 2.6 μm) operated in gradient mode. The mobile phase consisted of 0.1% v/v orthophosphoric acid as Mobile Phase A, and a mixture of Buffer: Isopropyl Alcohol: Acetonitrile (25:15:60) as Mobile Phase B, with a flow rate of 1.0 mL/min. Detection was carried out at 210 nm, and the retention time for Sugammadex was approximately 8.0 minutes.

The method demonstrated excellent linearity in the concentration range of 940–2800 μg/mL, with a mean %RSD for precision of 0.40% and mean % recovery ranging from 99.3% to 100.3%, confirming its accuracy and reproducibility. The stability-indicating capability of the method was established through forced degradation studies, ensuring reliable quantification in the presence of degradation products. The method was validated in accordance with ICH guidelines, confirming its suitability for routine quality control and stability testing of Sugammadex sodium injection.

KEYWORDS:

Sugammadex, RP-HPLC, Assay, Forced Degradation, Validation, Stability-Indicating Method