Development and validation of HPLC method for 6-Gingerol and 6-Shogaol in ginger capsules for the treatment of chemotherapy-induced nausea and vomiting

Abstract

Keywords: Ginger; 6-gingerol; HPLC; 6-shogaol; chemotherapy-induced nausea and vomiting

Objectives: The objective of this research is to develop and validate the analytical method of 6-gingerol (6G) and 6-shogaol(6S) in ginger capsules.

Methods: The chromatographic separation was achieved by using C18 column, 150 x 4.6mm i.d., 5μ Luna, mobile phase containing acetonitrile and water (gradient elution). The flow rate was 1.0 ml/min and the absorbance was monitored at 282  nm. The retention time of  6G and 6S was found to be 22.712 and 35.879  min. The proposed method was validated in terms of the analytical parameters such as specificity, accuracy, precision, linearity, range, limit of detection (LOD), limit of quantification (LOQ) and determined based on the International Conference on Harmonization (ICH) guidelines.

Results:The linearity range of 6G and 6S was obtained over 20-60 and 3-7 µg/ml, respectively. Good linearity was observed over the above-mentioned range with linear regression equation Y= 12001x- 29861 for 6G and Y = 29550x-41406 for 6S (x is concentration of analytes in μg/ml and Y is peak area). The values of correlation coefficient were found to be 0.9993 for 6G and 0.9994 for 6S.The limit of detection (LOD) and limit of quantification (LOQ) for 6G were 1.4730 and 4.9099 µg/ml and for 6S were 0.1846 and 0.6153 µg/ml, respectively. The recovery range for 6G and 6S were found to be 93.85 to 104.25 % and 93.77 to 108.47 % for all three spiked levels. The RSD values from repeated extractions for 6G and 6S were 1.24 and 0.33%, respectively.

Conclusion:The validation of developed method on precision, accuracy, specificity, linearity and range were also performed with well-accepted results.