Stability indicating method development and validation of semaglutide by RP-HPLC in pharmaceutical substance and pharmaceutical product

A New specific, economic and selective, accurate, precise and robust Reverse Phase High Performance Liquid Chromatography was developed for the quantification of Semaglutide in pharmaceutical substance and product. (28pg/ml of Semaglutide) Preparation of 28pg/ml of Semaglutide Sample Preparation: 5...

Full description

Saved in:
Bibliographic Details
Published in:Research journal of pharmacy and technology 2021-03, Vol.14 (3), p.1385-1389
Main Authors: Manasa, Merugu, Aanandhi, Vijey M
Format: Article
Language:English
Subjects:
Accuracy
Antidiabetics
Calibration
Chromatography
Diabetes
Pharmaceuticals
Potassium
Reproducibility
Standard deviation
Citations: Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:A New specific, economic and selective, accurate, precise and robust Reverse Phase High Performance Liquid Chromatography was developed for the quantification of Semaglutide in pharmaceutical substance and product. (28pg/ml of Semaglutide) Preparation of 28pg/ml of Semaglutide Sample Preparation: 5 tablets (Rybelsus) were weighed and the average weight of each tablet was calculated, then the weight equivalent to 1 tablet was transferred into a 50mL volumetric flask, 25mL of diluent added and sonicated for 25 min, further the volume made up with diluent and filtered. All the parameters like relative standard deviation, peak tailing and theoretical plate number were measured. LOD and LOQ were calculated by sung the formulas LOD = 3.3SD/S and LOQ = 10SD/S, where S= slope of calibration curve and SD = standard deviation of peak area. All the parameters like relative standard deviation, peak tailing and theoretical plate number were measured.
ISSN:0974-3618
0974-360X
0974-306X
DOI:10.5958/0974-360X.2021.00247.X