Validated HPTLC Method for the Quantitation of Andrographolide from Raw Material and Pharmaceutical Dosage Form

This paper describes a new, simple, precise, and accurate HPTLC method for quantitation of andrographolide in kalmegh extract and its pharmaceutical dosage form. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of toluene: ethyl acetate: formic acid: methanol 50:30:05:2.5 (v/v/v/v). Densitometric evaluation of the separated zones was performed at 226 nm. The andrographolide was satisfactorily resolved with R_F values of 0.34 ± 0.03 in both plant extract and pharmaceutical dosage form. The accuracy and reliability of the method was assessed by evaluation of linearity (100–800 ng spot-¹), precision (method precision RSD 1.52% and system precision RSD 1.38%), accuracy (97.34 ± 1.47) and specificity in accordance with ICH guidelines.