Development and validation of analytical technique for the evaluation of insulin glargine by RP-HPLC

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 μm 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 m-
cresol, 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 regressionr2= 0.998. During accuracy tests, it was revealed that the mean recovery was around 100.35 per cent. Arelatively inexpensive, dependable, accurate, linear, and quick RP-HPLC technique was created and verifiedin accordance with ICH guidelines requirements. This strategy has been demonstrated to be reliable, and itcan currently be used to routinely assess insulin glargine.