Validated stability indicating HPTLC methods for the determination of entecavir in bulk and dosage form
DOI:
https://doi.org/10.61096/ijpar.v8.iss2.2019.185-193Keywords:
Entecavir, High pressure thin layer chromatography, Method development and validation, Stability indicating.Abstract
The objective of the present work is to develop a simple, precise, accurate, validated stability indicating HPTLC method for the determination of Entecavir in bulk and tablet dosage form. The HPTLC method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of Chloroform:Toluene: methanol: ammonia (7:2:1:0.2v/v) and then scanned .The system was found to give compact spot for Entecavir (Rf value of 0.51 ± 0.02). The linearity was found to be in the concentration range 300-1800 ng/spot. The reliability and analytical performance of the proposed methods, including linearity, range, precision, accuracy, detection and quantitation limits, were statistically validated. When entecavir was subjected to different stress conditions; the proposed methods could effectively separate the drug from its degradation products, and were thus considered as good stability-indicating procedures. It is concluded that this method can be applied for routine quality control of Entecavir in dosage forms as well as in bulk drug.
