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         Andrographis Capsules contain an amount of powdered Andrographis Herb equivalent to not less than 80.0 per cent and not more than 120.0 per cent of the labelled amount of total lactones, calculated as andrographolide (C₂₀H₃₀O₅), and on the dried basis.

Strengths available 250, 300, 350, and 500 mg (powder).

Dose        Antidiarrheal: 0.5 to 2 g four times a day after meals and at bedtime.
                 Laryngitis: 0.75 to 1.5 g four times a day after meals and at bedtime.

Contra-indication It is contra-indicated in pregnant and nursing women and in patients with known allergy to plants of the Acanthaceae family.

Warning
          1. It should not be used for more than 2 days as antidiarrheal and for more than 7 days as anti-inflammatory in laryngitis.
          2. Concomitant use with anticoagulants, antiplatelets and antihypertensives should be avoided.

Additional information Animal studies show that andrographolide may increase a risk for carcinogenicity. Risk-benefit should be therefore considered when consuming. However, clinical data is not available at present.

Packaging and storage Andrographis Capsules shall be kept in well-closed containers, protected from light, and stored in a dry place and at a temperature not exceeding 30°.

Labelling The label on the container states (1) the equivalent amount of total lactones, calculated as andrographolide; (2) the amount of andrographolide in mg per capsule; (3) expiration date.

Identification
          A. The capsule contents exhibit diagnostic structures of the powdered drug described under Andrographis Herb.
          B. The capsule contents comply with the tests for Identification A, B and C described under Andrographis Herb.

Loss on drying Of the capsule contents, not more than 11.0 per cent w/w after drying at 105° to constant weight (Appendix 4.15).

Microbial limit Comply with the requirements for Category 4 in the “Limits for Microbial  Contamination” (Appendix 10.5).

Andrographolide content Not less than 1.0 per cent w/w of andrographolide (C₂₀H₃₀O₅). Carry out the determination as described in the “Liquid Chromatography” (Appendix 3.5).

          Mobile phase Prepare a mixture of 52 volumes of distilled water and 48 volumes of methanol. Make adjustments if necessary.

          Standard preparations Dissolve an accurately weighed quantity of andrographolide in sufficient methanol and dilute with Mobile phase to obtain a stock solution having a known concentration of about 200 μg per mL. Dilute this solution quantitatively, and stepwise with Mobile phase to obtain six solutions having known concentrations of 20, 40, 60, 80, 100, and 140 μg per mL.

          Sample preparation Remove, as completely as possible, the contents of not less than 20 Andrographis Capsules, and grind to fine powder. Transfer about 400 mg, accurately weighed, to a 100-mL round-bottomed flask. Add 50 mL of a mixture of equal volumes of dichloromethane and methanol, reflux in a water-bath for 30 minutes, and filter. Evaporate the filtrate at 50° under reduced pressure to dryness and dissolve the residue in sufficient methanol. Transfer quantitatively to a 100-mL volumetric flask, dilute with Mobile phase to volume and mix. Filter through a nylon membrane having a 0.45-μm porosity.

          Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (15 cm × 3.9 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (5 μm), (b) a guard column (20 mm × 3.9 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (5 μm), (c) Mobile phase at a flow rate of about 1 mL per minute, and (d) an ultraviolet photometer set at 224 nm.

          To determine the suitability of the chromatographic system, chromatograph Standard preparation having a known concentration of 60 μg per mL and record the peak responses as directed under Procedure and Calculation: the symmetry factor for the andrographolide peak is not more than 2.0 and the relative standard deviation for replicate injections is not more than 2.0 per cent

          Procedure and Calculation Separately inject about 20 μL each of Standard preparations into the chromatograph, record the chromatograms and measure the responses for the major peaks. Plot the readings and draw the standard curve of best fit. Inject about 20 μL of Sample preparation into the chromatograph, record the chromatogram and measure the response for the major peak. By reference to the standard curve, calculate the content of andrographolide (C₂₀H₃₀O₅) in the portion of the Capsules taken.

          Assay Grind the contents of not less than 20 Andrographis Capsules to fine powder. Transfer about 1 g, accurately weighed, to a 100-mL round-bottomed flask. Add 50 mL of ethanol (85 per cent), reflux in a water-bath for 2 hours and filter. Wash the marc with sufficient amount of ethanol (85 per cent) until the last washing is almost colourless. Combine the washings and the filtrate and allow to cool. Add 1 mL of basic lead acetate TS, set aside for 15 minutes, filter, and wash the precipitate with ethanol until the last washing is no longer green. Combine the washings and the filtrate, add dropwise with swirling 1 mL of a 25 per cent w/v solution of sodium sulfate and mix well. Set aside for 1 hour, add 500 mg of decolorizing charcoal, and reflux in a water-bath for 10 minutes. Filter through the Büchner funnel containing 500 mg of decolorizing charcoal and wash with three 2-mL portions of hot ethanol. Combine the washings and the filtrate, add 20 mL of distilled water, allow to cool, and neutralize with 0.1 M sodium hydroxide, using phenolphthalein TS as indicator. Add 5.0 mL of 0.1 M sodium hydroxide VS, reflux in a water-bath for 30 minutes, allow to cool, and titrate with 0.05 M hydrochloric acid VS. Perform a blank determination (Residual Titrations, Appendix 6.17). Each mL of 0.1 M sodium hydroxide VS is equivalent to 35.05 mg of total lactones calculated as andrographolide (C₂₀H₃₀O₅).

          Other requirements Comply with the requirements described under “Capsules” (Appendix 1.16H)