Validated stability indicating HPTLC methods for the determination of entecavir in bulk and dosage form


  • C. J. Bhangale PRES’s College of Pharmacy (For Women), Chincholi, Nashik.
  • D.H. Nandal Pravara Institute of Medical Sciences Deemed University (PIMS), Loni,


Entecavir, High pressure thin layer chromatography, Method development and validation, Stability indicating.


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.