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Validation of the developed method for the determination of high-molecular impurities in drug substance oF insulin glulisine by means of HPLC

Татьяна Герасимова, Александра Киселева, Ц. О. Бадмаева, Д. А. Гусаров, И. В. Степанюк, Т. С. Тарасова, Т. Г. Лосева

Abstract


GEROPHARM, JSC has developed a technology for the industrial production of insulin glulisine active drug ingredient. To quality control of the obtained substance, a method was developed for determining high-molecular impurities by HPLC with a spectrophotometric detector. Validation of this method was carried out according to all validation characteristics established by the Russian State Pharmacopoeia: specificity, limit of quantitation (LOQ), linearity, correctness, precision, analytical area and stability. The results obtained showed that the developed method meets the established acceptance criteria for all validation characteristics and provides reliable results for the determination of high-molecular impurities in the substance of insulin glulisine.

DOI: 10.30906/2073-8099-2023-15-3-45-52


Keywords


validation, PQS, linearity, precision, correctness, insulin glulisine, HPLC

References


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ISSN: 2073-8099

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