فصل شوائب الاصطناع و المصاوغات المرافقة لمركب كاناغليفلوزين Canagliflozin باستخدام الاستشراب السائل المزود بمكشاف طيف الكتلة LC-MS

الملخص EN

In this work, Impurities of canagliflozin in active pharmaceutical ingredient (API) and the product are detected and identified.

The related isomers are also separated using LC-MS technique, and all the applied analytical methods were validated Canagliflozin is a novel antidiabetic drug.

It works by inhibiting the sodium-glucose transport protein (SGLT2).

This transport protein is found in the kidney, which is responsible for reabsorbing glucose that has been filtered at kidney tubules.

this inhibition is decreasing blood sugar amount which absorbed in the body and increasing the amount of sugar that leaves the body in the urine.

The analyses and detections have been carried out using UV detector at 290 nm and Mass Spectrometer with Electro-Spray Ionization (ESI) mode.

The method was validated according to USP 35 guideline recommendations and the ICH guidelines for validation.

Impurities in the investigated drug were found to be around 0.1 ±% according to ICH guideline and therefore no need for isolation and identification.