Sennosides Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION 

Sennosides Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of Sennosides. 

2 IDENTIFICATION 

A. Thin-Layer Chromatographic Identification Test 

Solvent: Ethyl acetate, n-propyl alcohol, and water (1:1:1). Shake well, and discard the upper layer. Standard solution: 1 mg/mL of USP Sennosides RS in Solvent 

Sample solution: Shake a portion of finely powdered Tablets equivalent to 20 mg of sennosides with 20 mL of Solvent. Chromatographic system 

(See Chromatography 〈621〉, Thin-Layer Chromatography.) 

Adsorbent: 0.25-mm layer of chromatographic silica gel mixture 

Application volume: 20 µL 

Developing solvent system: Ethyl acetate, n-propyl alcohol, and water (4:4:3) 

Analysis: Proceed as directed in the chapter. Apply the solutions, as 1-cm streaks, on a line 2.5 cm from the bottom edge of a thin-layer chromatographic plate. Examine the plate under long-wavelength UV light. Expose the plate to ammonium hydroxide vapor until color develops (about 5 min). Cover the plate with a piece of glass, and heat at 120° for 5 min. 

Acceptance criteria: The two most prominent spots from the Sample solution correspond in color and mobility to those from the Standard solution. 

3 ASSAY 

Procedure 

Buffer: Dissolve 4.54 g of monobasic potassium phosphate in water to make 500 mL of solution. Dissolve 4.73 g of anhydrous dibasic sodium phosphate in water to make 500 mL of solution. Mix 38.9 mL of the monobasic potassium phosphate solution with 61.1 mL of the dibasic sodium phosphate solution. Adjust, if necessary, to a pH of 7.0 with the dibasic sodium phosphate solution. Borate solution: 37.9 g/L of sodium borate in water 

Sodium dithionite solution: 15 g/L of sodium dithionite in water 

Standard solution: 1 mg/mL of USP Sennosides RS in Buffer. Dissolve with the aid of an ultrasonic bath. 

Sample solution: Weigh and finely powder NLT 20 Tablets. Transfer a portion of the powder, equivalent to 25 mg of sennosides, to a 25-mL volumetric flask. Add 20 mL of Buffer, and sonicate to dissolve. Add additional Buffer to volume. Centrifuge the resulting suspension for 15 min at 3500 rpm. Use the supernatant. 

Instrumental conditions 

(See Fluorescence Spectroscopy 〈853〉.) 

Mode: Fluorescence 

Excitation wavelength: 392 nm 

Emission wavelength: 505 nm 

Analysis 

Samples: Standard solution and Sample solution 

Pipet 1-mL portions of the Standard solution and the Sample solution into separate 100-mL volumetric flasks, and dilute with Borate solution to volume. Transfer 5.0-mL portions of each of the resulting solutions to separate low-actinic glass, 50-mL volumetric flasks, and add 15 mL of Borate solution and 15.0 mL of Sodium dithionite solution. Pass nitrogen through the solutions, seal the flasks with nitrogen-filled balloons, and heat in a water bath for 30 min. Cool the flasks for 15 min in a water bath thermostatically controlled at 20°. Dilute the solutions with Borate solution to volume. Determine without delay the fluorescence intensities of the resulting solutions, for which the time elapsed between the addition of Sodium dithionite solution and the measurement is the same. Calculate the percentage of the labeled amount of sennosides in the portion of Tablets taken: 

Result = (I_U/I_S) × (C_S/C_U) × 100 

I_U = fluorescence value observed in the Sample solution 

I_S = fluorescence value observed in the Standard solution  

C_S = concentration of USP Sennosides RS in the Standard solution (mg/mL)  

C_U = nominal concentration of sennosides in the Sample solution (mg/mL)  

Acceptance criteria: 90.0%–110.0% 

4 PERFORMANCE TESTS 

Dissolution 〈711〉 

Medium: Water; 900 mL 

Apparatus 1: 100 rpm 

Time: 120 min 

Analysis: Determine the amount of sennosides dissolved, using the procedure set forth in the Assay, making any necessary volumetric adjustments. 

Tolerances: NLT 75% (Q) of the labeled amount of sennosides is dissolved. 

Uniformity of Dosage Units 〈905〉: Meet the requirements 

5 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in well-closed containers. 

USP Reference Standards 〈11〉 

USP Sennosides RS