ตำรายาของประเทศไทย
Thai Pharmacopoeia
สำนักยาและวัตถุเสพติด กรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข
Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health Gentian 1 part
Ethanol (70 Per Cent) 5 parts
Prepare by a suitable procedure (Appendix 7.18).
Description Yellowish brown or reddish brown liquid; taste, bitter.
Identification Carry out the test as described in the “Thin-Layer Chromatography” (Appendix 3.1).
Standard solution Dissolve 5 mg of hyperoside, and 5 mg of phenazone in 10 mL of methanol.
Test solution Use Gentian Tincture.
Adsorbent Silica gel F254.
Mobile phase Water, anhydrous formic acid and ethyl formate (4:8:88).
Application Apply 20 µL each of Standard solution and the tincture as 10-mm bands.
Development and drying Allow the solvent front to ascend 8 cm above the line of application in an unsaturated tank. Dry the developed plate in air.
Detection A Examine the plate under ultraviolet light (254 nm).
Results A When examined under ultraviolet light (254 nm), the test solution shows a prominent quenching band due to gentiopicroside in the lower third of the chromatogram, corresponding in Rf to the quenching band of hyperoside shown by the standard solution. There is also a weak quenching band due to amarogentin in the middle and a prominent quenching band in the upper third of the chromatogram.
A quenching band of phenazone obtained from the standard solution appears also in the upper third with Rf value between that of amarogentin and of the prominent quenching band from the test solution
Detection B Spray the plate with a 10 per cent w/v solution of potassium hydroxide in methanol and then spray with a freshly prepared 0.2 per cent w/v solution of fast blue B salt in a mixture of equal volumes of anhydrous ethanol and water. Examine the plate under visible light.
Results B When examined under visible light, the test solution shows a weak light brown band due to gentiopicroside in the lower third of the chromatogram, corresponding in Rf to the brownish red band due to hyperoside shown by the standard solution. A violet-red band due to amarogentin and a dark violet band of higher Rf value in the upper third of the chromatogram are present.
Ethanol content 62 to 67 per cent v/v (Method II, Appendix 6.5).
Dry residue Not more than 5 per cent w/w. Introduce rapidly 3.0 g of the Gentian Tincture in a flat-bottomed dish, about 50 mm in diameter and about 360 mm deep. Evaporate to dryness on a water-bath and dry at 105° for 3 hours. Allow to cool in a desiccator over self-indicating silica gel and weigh.
Other requirements Complies with the requirements described under “Tinctures” (Appendix 1.16).