Development and validation of analytical technique for the evaluation of insulin glargine by RP-HPLC
Dhritimoni Devi, M. Sumithra
Abstract
A rapid, exact, trustworthy, and repeatable RP-HPLC method was created for the determination of insulin glargine.Adjusting pH 2.5 with sodium dihydrogen phosphate anhydrous buffer is used as the mobile phase-A in the most recent validated gradient RP-HPLC analytical technique for detecting insulin glargine: acetronitrile R1, buffer solution (7:93 V/V) and mobile phase-B: buffer solution, acetronitrile R1 (43:57 V/V).Waters, synergi 4 m fusion-RP 80 A 250 3 mm (phenonmenox), column: size l = 0.125 m, f =3.0 mm with a flow rate of 0.55 ml/min, samples were allocated.It was found that 214 nm is the wavelength at which ultraviolet detection occurs.The technique was evaluated in the presence of phenol and mcresol, and these are present in low concentrations in commercial insulin glargine preparation as preservatives, as well as for the purpose of research on insulin glargine and its desamido degradation product.These preservatives are present in commercial insulin glargine preparations as well.The method's linearity over the measured concentration between 12 to 18 mg/ml was found, with coefficient regression r 2 = 0.998.During accuracy tests, it was revealed that the mean recovery was around 100.35 per cent.A relatively inexpensive, dependable, accurate, linear, and quick RP-HPLC technique was created and verified in accordance with ICH guidelines requirements.This strategy has been demonstrated to be reliable, and it can currently be used to routinely assess insulin glargine.