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A validated high-performance thin-layer chromatography method for the simultaneous quantification of 6-gingerol, guggulsterone E and guggulsterone Z in coded formulation AYUSH SG-5 prepared for rheumatoid arthritis

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SPRINGER HEIDELBERG
DOI: 10.1007/s00764-022-00153-9

关键词

6-Gingerol; Guggulsterone E; Guggulsterone Z; Ayush SG; High-performance thin-layer chromatography (HPTLC)

资金

  1. CCRAS IMR Project [F.3-87/2020-CCRAS/Admn/IMR/2868]

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A new, simple, selective, sensitive, precise, and robust high-performance thin-layer chromatography (HPTLC) method was developed and validated for the simultaneous quantification of 6-gingerol, guggulsterone E, and guggulsterone Z in coded formulation AYUSH SG-5 (for rheumatoid arthritis).
A new, simple, selective, sensitive, precise, and robust high-performance thin-layer chromatography (HPTLC) method for the simultaneous quantification of 6-gingerol, guggulsterone E, and guggulsterone Z in coded formulation AYUSH SG-5 (for rheumatoid arthritis) was developed and validated. Analysis of 6-gingerol, guggulsterone E, and guggulsterone Z was performed on thin-layer chromatography (TLC) aluminum plates pre-coated with silica gel 60F(254) as the stationary phase. Linear ascending development was carried out in CAMAG twin-trough glass chamber saturated with a mobile phase consisting of toluene-acetone (9:1, V/V) at room temperature (25 +/- 2 degrees C). CAMAG TLC scanner was used for spectrophotometric scanning and analysis in absorbance mode at 280 nm. The system was found to give compact spots for 6-gingerol (R-F value 0.149 +/- 0.022) scanned at 545 nm and guggulsterone E (R-F value 0.192 +/- 0.025) and guggulsterone Z (R-F value 0.249 +/- 0.028) scanned at 254 nm. The linear regression analysis data for the calibration plots exhibited a good linear relationship with r(2) = 0.9992 +/- 0.02 in the concentration range 100-1200 ng spot(-1) with respect to the peak area. The method was validated as per the International Council for Harmonisation (ICH) guidelines to examine the validity, precision, robustness, ruggedness, limits of detection and quantification. The quantified and estimated amount of 6-gingerol, guggulsterone E, and guggulsterone Z in AYUSH SG-5 as well as in raw drugs was found to be well within limits (5% of the labeled content). Statistical analysis of the data manifested that the method is reproducible and sensitive for the simultaneous estimation and quantification of 6-gingerol, guggulsterone E, and guggulsterone Z.

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