Abstract
Abstract Background Among different systems medicine practiced worldwide, Unani medicine is the classical one and still commonly practiced in India and abroad for centuries. As it is widely used by a majority of population, it is necessary to come up with a systematic approach to develop well-designed methodologies for the quality control of different polyherbal formulations which are used for treatment of various diseases in this system of medicine. Methods A reverse phase stability indicating HPLC method was developed for the determination of 6-gingerol in polyherbal formulations. Separation of 6-gingerol was achieved on reverse phase C18 (250 × 4.6 mm) column with a mobile phase containing methanol: 0.05% orthophosphoric acid in water (60:40, v/v) at 280 nm using UV-visible detector. The flow rate was kept as 1 mL/min. The proposed method was validated according to ICH guidelines for accuracy, precision, robustness, LOD, and LOQ, and statistical analysis proved method was accurate, precise, and robust. Results The linear regression analysis data showed a good linear relationship (r 2 = 0.9989 ± 0.0010) for 6-gingerol in the concentration range of 0.5 μg to 500 μg/mL. This proved the method can be employed for the determination 6-gingerol even in nanogram levels. The detection (LOD) and quantification (LOQ) limits were found to be 0.05 μg and 0.18 μg/mL, respectively. Satisfactory recovery results were observed from the herbal compound formulations (98.5 to 101%). Intra- and inter-day precisions of the method were found convincing, with relative standard deviation (%RSD) values in the range of 0.5 to 1.9%. Forced degradation studies of 6-gingerol was also carried out under different stress conditions which showed that the drug is stable in acidic and basic conditions whereas unstable against dry heat. Conclusions Hence, newly validated HPLC method can be used for the quality control and standardization of different herbal formulations which contain Zingiber officianalis as one of the ingredients.
Highlights
Among different systems medicine practiced worldwide, Unani medicine is the classical one and still commonly practiced in India and abroad for centuries
The developed HPLC method will help in the quality control and standardization of many herbal compound formulations which contain Zingiber officinale as one of the active ingredients
In methanol and water, when used in the composition of 50:50 v/v, standard has given a sharp peak with RT around 10 min, but in sample, separation of 6-gingerol from the immediate impurities was unsatisfactory
Summary
Reagents and chemicals 6-Gingerol (98.5%) was obtained as gift sample from Sami Labs Ltd., Bangalore, India. Two grams of powdered sample was transferred into a 50-mL conical flask having about 20 mL of methanol and sonicated for 20 minutes at room temperature It was filtered using Millipore water purification System (New Orleans, USA) and filtrate was made up to volume 10 mL in volumetric flask with HPLC grade methanol. This was again filtered through 0.22-μm syringe filter prior to injection. Base-induced degradation study Freshly prepared solution of 6-gingerol (1,000 μg/mL) in 0.1 M methanolic NaOH was transferred to a 100-mL volumetric flask, warmed at 30°C for 5 min, and allowed to stand for 1 h for the completion of degradation reaction at room temperature, neutralized using dilute HCl solution, and make up the volume with methanol (100 μg/mL solution). The solution was injected in HPLC along with the blank solution, and the chromatogram was analyzed for peak purity and resolution between the peaks
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