Abstract

Mahreen Fatima¹, Anupama Koneru², M.Mushraff Ali Khan³, Murali Balaram Varanasi¹ and Imam Pasha Syed^1*

DOI : http://dx.doi.org/10.13005/ojc/360216

A stability indicating HPLC method for the quantification of Larotrectinib in capsule form was developed and validated as per the ICH guidelines. Separation and quantification of Larotrectinib was carried out on column Sunsil C18 using mobile phase as KH2PO4 and methanol in 1:1 ratio. Larotrectinib was eluted at 3.432 minutes. Linearity was observed in between 50-150 µg/ml. LOD and LOQ were found to be 0.065 µg/ml and 0.217 µg/ml respectively. % RSD for the precision of the method was found to be 0.115. Accuracy was well within the regulated limit that is 100.13% and the recovery was found to be to 100.47%. Forced degradation analysis was carried out on Larotrectinib which established stability indicating power of the developed method.

HPLC; ICH Guidelines; Larotrectinib; Method Development

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