Analytical Quality by design for developing a validated HPTLC densitometry method for estimating mangiferin in human plasma
- Khurana Rk et.al
- Curr Pharm Anal,
Introduction There are so many promising plant based chemical constituents are present which act as alternative therapy for the control of diabetes. But due to lack of its proper quality control parameters they are not widely used. Mangiferin is a xanthone glucoside and active phytochemical principle which is present Mangifera Indica. Studies suggest that mangiferin, xanthone compound possesses anti diabetic activity. Objective In the present study a novel stability-indicating high-performance thin-layer chromatography (HPTLC) method for quantitative determination of Mangiferin in bulk drug and formulation has been developed and validated as per ICH guideline Q2(R1) for global acceptance of standardized Herbal formulations. Methodology – HPTLC method is developed and validated using solvent Ethyl acetate: Ethanol: Formic acid (10:1.5:1v/v/v) (Rf of Mangiferin 0.66 ± 0.03) in the absorbance mode at 340 nm. Various forced degradation conditions were used to check degradation of drug. Results The method showed a good linear relationship (r = 0.9965) in the concentration range 200-1000 ng per spot. It was found to be linear, accurate, precise and specific. Conclusion It can be applied for quality control as well as for stability testing of different dosage forms containing mangiferin. The developed method is validated as per ICH guideline Q2(R1) for global acceptance of standardized herbal formulations.