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       Andrographis Dry Extract Capsules are prepared from Andrographis Dry Extract and contain not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of andrographolide (C₂₀H₃₀O₅), calculated on the dried basis.

Strengths available 200 to 400 mg (equivalent to 10 to 20 mg of andrographolide)

Dose Three to six capsules three times a day after meals or as directed by physicians.

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 7 days as anti-inflammatory in laryngitis.
       2. Concomitant use with anticoagulants, antiplatelets, and antihypertensives should be avoided.

Additional information Some clinical studies show the potential of andrographis paniculata-containing formulations for alleviating the symptoms of common cold and declining the severity of COVID-19 infection.

Packaging and storage Andrographis Dry Extract Capsules shall be kept in tightly closed containers, protected from light, and stored at a temperature not exceeding 30º.

Labelling The label on the container states (1) the amount of andrographolide; (2) the expiration date.

Identification The chromatogram of the Assay preparation shows several peaks, one of which corresponds to that of the Standard preparation, as obtained in the Assay.

Loss on drying Not more than 5.0 per cent w/w after drying at 105° to constant weight (Appendix 4.15). Use 2.0 g.

Microbial limit Comply with the requirements for Category 1A in the “Limits for Microbial Contamination” (Appendix 10.5).

Assay Carry out the determination as described in the “Liquid Chromatography” Appendix 3.5).
       Mobile phase Prepare a mixture of equal volumes of methanol and water.
       Standard preparations Transfer about 5 mg of Andrographolide RS, accurately weighed, to a 25-mL volumetric flask, add 2 mL of methanol, and sonicate for 5 minutes. Dissolve and dilute with Mobile phase to volume to obtain a stock solution having a known concentration of about 200 µg of andrographolide per mL. Dilute this solution quantitatively and stepwise with Mobile phase to obtain seven solutions having known concentrations of 10, 20, 40, 60, 80, 100, and 140 µg per mL. Filter through a nylon membrane having a 0.45-µm porosity.
       Assay preparation Weigh and mix the contents of not less than 20 Andrographis Dry Extract Capsules. Transfer an accurately weighed portion of the capsule contents, containing about 10 mg of andrographolide, to a 100-mL volumetric flask. Add 10 mL of methanol and sonicate for 5 minutes. Add 60 mL of Mobile phase, sonicate for 15 minutes, and stand for 30 minutes. Dilute with Mobile phase to volume and mix. Pass a portion of the clear solution through a filter having a 0.45-µm or finer porosity.
       Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (15 cm × 4.6 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (5 µm), equipped with a similarly packed guard column, (b) Mobile phase at a flow rate of 1.0 mL per minute, and (c) 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: 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. The curve shows the correlation coefficient of not less than 0.999. Inject about 20 µL of Assay preparation into the chromatograph, record the chromatograms, 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.

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