Green stability indicating HPTLC Method for the Determination of Abacavir , Lamivudine and Dolutegravir in Bulk and Dosage Form

Abstract

Objective:  To develop a green and robust  stability-indicating high-performance thin- layer chromatographic method for densitometric determination of Abacavir(ABV) , Lamivudine(LMV) and Dolutegravir(DTG) in bulk and  dosage form by implementing GAC principles.

Methods: Chromatographic separation was carried by using TLC aluminium plates precoated with silica gel 60F 254 –(Merck, Germany) as the stationary phase. The solvent system of  Ethanol:Acetone:Ammonia (7:3:0.2v/v/v) was used for the development and  measurement  was performed  at 273nm. The proposed method subjected to different stress condition .The  method was assessed using green assessment tools such as National Environmental Methods Index(NEMI),Analytical Eco-Scale(AES),Green Analytical Procedure Index(GAPI) and Analytical GREEnness (AGREE).

Findings: The system was found to give very well resolved spot for Dolutegravir, Lamivudine and Abacavir at Rf value of 0.24, 0.39 and 0.59 respectively. .The calibration curve of the drug 200 -1600 ng/spot for DTG, 500 to 4000 ng/spot for LMV and concentration range  1000-8000 ng/spot for ABV was observed. The correlation of coefficient was found to be 0.9991 for DTG, 0.9996 for LMV and 0.9994 for ABV. The method was validated as per International Conference on Harmonization (ICH) guidelines. The %RSD less than two indicates method is precise and accurate. The degradation products were well resolved from the pure drug with significantly different retention factor in HPTLC.The developed method has been assessed for its greenness .The results show a score of nine green pictograms out of fifteen for GAPI, four green parts in NEMI, a score of 97 for AES which is near to 100, a score of 0.88 for AGREE indicates that the developed method is entirely eco- friendly and adaptable as a sustainable method.

Novelty: The method was proved as a eco-friendly stability indicating method and can be used in practice for bulk and the dosage forms and also to evaluate the shelf life