For the estimation of Insulin, a quick, precise, reliable, and repeatable RP-HPLC method was
developed. The latest established isocratic RP-HPLC analytical method for determining
insulin uses a pH 2.3 sodium sulphate anhydrous buffer as mobile phase-A and acetonitrile
(76:26) as mobile phase-B. Waters, Zorbax C18, (150X4.6mm), 3.5m column with a flow
rate of 1.0 mL/min was used to separate the samples. The wavelength of ultraviolet detection
was discovered to be 214 nm. This method was tested in the presence of phenol and m-cresol,
which are present in low concentration in commercial insulin preparations as preservatives,
with good distinction between their peaks, for the study of insulin and its desamido
degradation product, as well as in the presence of phenol and m-cresol, which are present in
low concentration in commercial insulin preparations as preservatives. With coefficient
regression r2 = 0.9994, the procedure was found to be linear over the concentration range 40-
60 g / ml. During accuracy tests, the mean recovery was found to be in the range of 100.35
percent. According to ICH guidelines, a low-cost, reliable, precise, linear, and rapid RPHPLC method was developed and validated. This approach has been shown to be accurate,
and it can now be used to analyse Human Insulin on a regular basis.
Keywords: Human Insulin, RP-HPLC, Diabetes, Degradation, Mobile phase, Isocratic
Publication date: 01/05/2022
https://ijbpas.com/pdf/2022/May/MS_IJBPAS_2022_6086.pdf
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https://doi.org/10.31032/IJBPAS/2022/11.5.6086
