Garcinia cambogia consists of the dried pericarp of the fruits of Garcinia gummi-gutta (L.) N. Robson, also known as Garcinia cambogia (Gaertn.) Desr. (Fam. Clusiaceae). It contains NLT 12% of the sum of ()-hydroxycitric acid and ()-hydroxycitric acid lactone, on the dried basis.
• A. Garcinia cambogia meets the requirements under Specific Tests, Botanic Characteristics.
• B. HPLC Identification Test: The Sample solution chromatogram exhibits a peak for hydroxycitric acid at a retention time corresponding to that of Standard solution A, as obtained in the test for Content of ()-Hydroxycitric Acid and ()-Hydroxycitric Acid Lactone. The Sample solution also exhibits a peak for hydroxycitric acid lactone. The hydroxycitric acid and the hydroxycitric acid lactone peaks are the main peaks in the Sample solution chromatogram.
• Content of ()-Hydroxycitric Acid and ()-Hydroxycitric Acid Lactone
Solution A: 30% phosphoric acid in water
Mobile phase: Dissolve 1.36 g of anhydrous potassium dihydrogen phosphate in 900 mL of water, adjust with Solution A to a pH of 2.5, complete to 1000 mL with water, mix, filter, and degas.
Solvent: A mixture of Solution A and water (1:9)
Standard solution A: A solution of USP Calcium ()-Hydroxycitrate RS equivalent to about 2.5 mg/mL of ()-hydroxycitric acid in Solvent. Before injection, pass through a membrane filter of 0.45-µm or finer pore size, discarding the first few mL of the filtrate.
Standard solution B: 5 mg/mL of USP Powdered Garcinia Hydroxycitrate Extract RS in Solvent. Before injection, pass through a membrane filter of 0.45-µm or finer pore size.
Sample solution: Transfer about 5 g of Garcinia cambogia, finely powdered and accurately weighed, to a 250-mL round-bottom flask fitted with a reflux condenser. Add 50 mL of Solvent, reflux while stirring on a water bath for 30 min, set aside to settle, and decant the supernatant. Repeat the extraction using four 50-mL portions of water, combine all extracts, cool, filter into a 250-mL volumetric flask, and complete with water to volume. Before injection, pass through a membrane filter of 0.45-µm or finer pore size, discarding the first few mL of the filtrate.
Detector: UV 215 nm
Column: 4.6-mm × 25-cm; packing L1
Column temperature: 25 ± 1
Flow rate: 1.0 mL/min
Injection size: 20 µL
Samples: Standard solution A, Standard solution B, and Sample solution
[NoteThe relative retention times for the hydroxycitric acid lactone and hydroxycitric acid peaks are about 0.9 and 1.0, respectively. ]
Chromatogram similarity: The chromatogram from Standard solution B is similar to the reference chromatogram provided with the lot of USP Powdered Garcinia Hydroxycitrate Extract RS being used.
Resolution: NLT 1.0 between hydroxycitric acid lactone and hydroxycitric acid, Sample solution
Tailing factor: NMT 2.0 for the hydroxycitric acid peak, Standard solution A
Relative standard deviation: NMT 2.0%, determined from the hydroxycitric acid peak in repeated injections, Standard solution A
Samples: Standard solution A, Standard solution B, and Sample solution. [NoteStandard solution A, Standard solution B, and Sample solution are stable for 6 h. ]
Calculate the percentages of ()-hydroxycitric acid and ()-hydroxycitric acid lactone in the portion of Garcinia cambogia taken:
Result = (rU/rS) × CS × (V/W) × F × 100
Acceptance criteria: Add the percentages of ()-hydroxycitric acid and ()-hydroxycitric acid lactone: NLT 12% is found on the dried basis.
• Heavy Metals, Method III 231: NMT 20 ppm
• Procedure 1: Articles of Botanical Origin, Foreign Organic Matter 561: NMT 2.0%
• Procedure 2: Articles of Botanical Origin, General Method for Pesticide Residues Analysis 561: Meets the requirements
• Botanic Characteristics
Macroscopic: Fresh fruits are spherical to oval in shape, 48 cm in height, 36 cm in width, yellowish to pale pinkish when ripe, resemble a miniature pumpkin, with 713 deep longitudinal grooves, extending up to a circular elevated base of stigma with blackish tip, situated in the depressed end of the fruit, containing 68 seeds surrounded by a succulent aril. Compendial article consists of dried pieces of pericarp, longitudinal, of variable size and shape, strongly curved inward; leathery; externally rough, irregularly wrinkled, longitudinally grooved; internally smooth, longitudinally faintly striated and ridged. Dark brown to blackish-brown; odor characteristic; taste sour, astringent, and slightly bitter.
Transverse section of the pericarp: Shows a layer of epicarp, composed of rectangular to tangentially elongated cells covered with thin cuticle; wide mesocarp, composed of 100150 rows of parenchyma cells of variable size and shape, the outer rows composed of relatively larger cells with wide intercellular spaces; vascular bundles appear throughout the mesocarp, more toward the inner zone; dark brown gummy exudates, simple and compound starch granules and prisms of calcium oxalate are present in the parenchyma cells throughout the mesocarp.
• Limit of Citric Acid
Solvent and Chromatographic system: Prepare as directed in the test for Content of ()-Hydroxycitric Acid and ()-Hydroxycitric Acid Lactone.
Standard solution: 0.5 mg/mL of USP Citric Acid RS in Solvent. Before injection, pass through a membrane filter of 0.45-µm or finer pore size, discarding the first few mL of the filtrate.
Sample: Standard solution
Calculate the percentage of citric acid in the portion of Garcinia cambogia taken:
Result = (rU/rS) × CS × (V/W) × 100
Acceptance criteria: NMT 2% of citric acid on the dried basis
• Loss on Drying 731: Dry 2.0 g of finely powdered Garcinia cambogia at 105 for 3 h: it loses NMT 12.0% of its weight.
• Articles of Botanical Origin, Total Ash 561: Determined on 1.0 g of finely powdered Garcinia cambogia: NMT 3.0%; and NMT 8.0% if sodium chloride was added as a preservative during collection of the fruits
• Microbial Enumeration Tests 2021: The total aerobic bacterial count does not exceed 105 cfu/g, the total combined molds and yeasts count does not exceed 103 cfu/g, and the bile-tolerant Gram-negative bacteria do not exceed 103 cfu/g.
• Microbiological Procedures for Absence of Specified Microorganisms 2022: Meets the requirements of the tests for absence of Salmonella species and Escherichia coli
• Packaging and Storage: Preserve in well-closed containers, protected from light and moisture, and store at room temperature.
• Labeling: The label states the Latin binomial and, following the official name, the part of the plant contained in the article.
• USP Reference Standards 11
USP Calcium ()-Hydroxycitrate RS
USP Powdered Garcinia Hydroxycitrate Extract RS
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USP35NF30 Page 1302Pharmacopeial Forum: Volume No. 36(3) Page 699