REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF SUGAMMADEX IN BULK AND PHARMACEUTICAL DOSAGE FORM

BHAVYA SRI K; SRIJA G

doi:10.22159/ajpcr.2024v17i7.50784

Authors

BHAVYA SRI K Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Hyderabad, Telangana, India.
SRIJA G Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Hyderabad, Telangana, India.

DOI:

https://doi.org/10.22159/ajpcr.2024v17i7.50784

Keywords:

Sugammadex, Reverse-phase high-performance liquid chromatographic, High-performance liquid chromatographic acetonitrile, High-performance liquid chromatographic water, International conference of harmonization guidelines Q2

Abstract

Objective:A reproducible, precise, accurate method was developed for the analysis of Sugammadex in pharmaceutical dosage form and bulk, using RP-HPLC. This method is established in compliance with ICH guidelines Q2R1.

Method:The method development and method validation of Sugammadex was performed usingthe instrument, SHIMADZULC- 20 AD pumps with SPD- 20A UV detector. A Phenomenex C18 250mm × 4.6mm × 5µm column was employed with detection wavelength of 210 nm.

Results: The method validation was performed in accordance with ICH Q₂R(1) guidelines where the calibration curve was found to be linearwith r²as 0.9993. The LOD and LOQ were found to be 0.03784µg/ml and 0.114667µg/ml respectively.The %RSD of theprecision wasobserved to be in limits (≤2%).

Conclusion:All validation parameters, including linearity, range, detection limit, quantification limit, precision, and accuracy, were examined and found to be within the specified limits in accordance with ICH recommendations Q2 (R1). In view of this, adopting this approach for routine quality control tests of both pure and pharmaceutical formulation can be done with ease.

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