Stability indicating Analytical Method development and Validation for the detection of Sugammadex in bulk and formulation

Abstract

Sugammadex is a selective relaxant binding agent indicated for the reversal of neuromuscular blockade induced during surgery. Degradation studies like photolytic degradation, and hydrolysis, were carried out, and the degradation was within 20%. For the analysis of Sugammadex, determination using the Ultra violet-Visible spectroscopic method was developed and validated using an ELICO SL210 UV-Visible spectrophotometer with spectral treats software according to ICH guidelinesQ2(R1) & Q2 (R2). The Sugammadex is soluble in water hence, the diluent used in this method is double distilled water whose absorbance was scanned in the UV range (200nm-400nm), the absorbance maxima with defined peaks were observed at 214nm and 380nm but the absorbance at 214nm was considered to be the absorbance maxima as absorbances for the further dilutions had better reproducibility. The method was then validated with the validation parameters like linearity, range, precision, accuracy, ruggedness, and robustness as mentioned in the ICH guidelines. Linearity was well observed for the concentration series of 10µg/ml to 500µg/ml, and the correlation coefficient (r2) was observed to be 0.999. Precision was carried out, its %RSD was observed to be within the limit. The other parameters’ robustness, ruggedness, and accuracy were performed with their respective %RSD within the limit as suggested by the ICH guidelines. The method validation was discovered to be precise, robust, reproducible, and repeatable helping the study to use UV spectrophotometry as an approachable method for the evaluation of Sugammadex.