สารบัญ

      Fingerroot Capsules contains an amount of powdered Fingerroot equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of pinostrobin (C₁₆H₁₄O₄), and not less than 80.0 per cent of the labelled amount of volatile oil, calculated on the anhydrous basis.
Strength available 500 mg (powder).
Dose Three to four capsules three times a day after meals.
Packaging and storage Fingerroot Capsules shall be kept in well-closed containers, protected from light, and stored at a temperature not exceeding 30°.
Labelling The label on the container states (1) the amount of pinostrobin in mg per sachet;
(2) the amount of volatile oil; (3) the expiration date.
Identification
     A. The capsules contents exhibit diagnostic structures of the powdered drug described
under Fingerroot.
     B. The capsules contents comply with the tests for Identification A, B, and C described
under Fingerroot.
Water Of the capsule contents, not more than 9.0 per cent v/w (Azeotropic Distillation
Method, Appendix 4.12).
Microbial limit Comply with the requirements for Category 4 in the “Limits for Microbial
Contamination” (Appendix 10.5).
Assay
FOR VOLATILE OIL Remove, as completely as possible, the contents of not less than
20 Fingerroot Capsules, mix, and transfer about 10 g, accurately weighed, to a 500-mL
round-bottomed flask. Use 100 mL of water as the distillation liquid and distil at a rate of
2 to 3 mL per minute for 5 hours. Use 2.0 mL of xylene in the graduated tube (Appendix 7.3H).  Calculate the content of volatile oil, in mL, in the portion of the Capsules taken with
reference to the anhydrous substance.
FOR PINOSTROBIN Carry out the determination as described in the “Liquid Chromatography”
(Appendix 3.5).
    Mobile phase A Prepare a mixture of equal volumes of methanol and acetonitrile.
    Mobile phase B Use water.
    Standard preparations Dissolve a suitable quantity of pinostrobin, accurately weighed,
in sufficient methanol to obtain a stock solution having a known concentration of about 1 mg
of pinostrobin per mL. Dilute the solution quantitatively and stepwise with the same solvent
to obtain five solutions having known concentrations ranging from 40 to 240 μg per mL.
    Assay preparation Remove, as completely as possible, the contents of not less than
20 Fingerroot Capsules and grind to fine powder. Macerate about 100 mg, accurately weighed, in 20.0 mL of methanol for 24 hours. Pass a portion of the supernatant through a 0.22-μm polyvinylidene fluoride filter.

The step gradient of mobile phases is as follows:

      Chromatographic system The chromatographic procedure may be carried out using
(a) a stainless steel column (5 cm × 2.1 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (1.7 μm), (b) Mobile phase at a flow rate of about 0.6 mL per minute, and (c) an ultraviolet photometer set at 290 nm.
      To determine the suitability of the chromatographic system, chromatograph Standard
preparation having a known concentration of 120 μg per mL, and record the peak response
as directed under Procedure and Calculation: the relative standard deviation for replicate
injections is not more than 2.0 per cent.
     Procedure Separately inject about 2 μL each of Standard preparations into the
chromatograph, record the chromatograms, and measure the responses for pinostrobin peaks.  Plot the readings and draw the standard curve of best fit: the curve shows the correlation coefficient of not less than 0.999. Inject about 2 μL of Assay preparation into the chromatograph, record the chromatogram, and measure the response for pinostrobin peak.
     Calculation By reference to the standard curve, calculate the content of pinostrobin
(C₁₆H₁₄O₄) in the portion of the Capsules taken.
Other requirements Comply with the requirements described under “Capsules” (Appendix
1.16H).