Abstract
Objective: In the present study a novel stability-indicating high-performance thin-layer chromatography (HPTLC) method for quantitative determination of Swertiamarin (SW) in bulk drug and formulation has been developed and validated as per ICH guideline Q2 (R1) for global acceptance of standardized herbal formulations.Methods: HPTLC method is developed and validated using solvent ethyl acetate: ethanol: chloroform (3:2.5:4.5 v/v/v) (Rf of SW 0.65±0.04) in the absorbance mode at 243 nm. Various forced degradation conditions were used to check degradation of drug.Results: The method showed a good linear relationship (r2 = 0.9990) in the concentration range 200-700 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 swertiamarin. The developed method is validated as per ICH guideline Q2(R1) for global acceptance of standardized herbal formulations.
Highlights
Herbal medicinal technology is used for exploring medicinal plant materials as medicines, where standardization and quality control with proper integration of modern scientific techniques and traditional knowledge is important
The sensitivity of high-performance thin-layer chromatography (HPTLC) method with UV detection depends upon the proper selection of detection wavelength
Degradation study is a requirement of ICH guidelines
Summary
Herbal medicinal technology is used for exploring medicinal plant materials as medicines, where standardization and quality control with proper integration of modern scientific techniques and traditional knowledge is important. The chromatographic techniques and marker compounds are used to standardize herbal formulations [1]. The stability indicating assays are important to determine the shelf life of the products. It helps to determine the storage conditions by knowing the process of degradation. It is carried out by performing forced degradation studies. These types of studies using sophisticated techniques are important for global acceptance of herbal products [2]
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