CHEMOMETRICS ASSISTANT RP - HPLC METHOD DEVELOPMENT AND VALIDATION OF COLLAGEN TYPE II AND UNIVESTIN

Authors

  • Dr. SWAPNA.GODAY* , SHAIK SAHEERA BEGUM Author

DOI:

https://doi.org/10.48047/

Keywords:

UC-II,Univestin, RP-HPLC, Development, Validation.

Abstract

The current investigation was pointed at developing and progressively validating novel, simple, responsive and
stable RP-HPLC method for the estimation of UC-II and Univestin.The chromatographic strategy utilized Chiral
Cell ODH 150x4.6mm, 5µ, using isocratic elution with a mobile phase of Hexane + THF and 0.1% Formic Acid
(80+20). A flow rate of 1 ml/min and a detector wavelength of 308 nm utilizing the PDA detector were given in the
instrumental settings.Validation of the proposed method was carried out according to an international conference on
harmonization (ICH) guidelines.LOD and LOQ for the two active ingredients were established with respect to test
concentration. The calibration charts plotted were linear with a regression coefficient of R2 > 0.999, means the
linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as
a part of method validation and the results were found to be within the acceptable range. The proposed method to be
fast, simple, feasible and affordable in assay condition. 

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Published

2021-04-21