Hyoscyamine Sulfate Tablets
» Hyoscyamine Sulfate Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hyoscyamine sulfate [(C17H23NO3)2·H2SO4·2H2O].
Packaging and storage— Preserve in tight, light-resistant containers.
A: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
B: A filtered solution of Tablets meets the requirements of the tests for Sulfate 191.
Disintegration 701: 15 minutes.
Uniformity of dosage units 905: meet the requirements.
Diluent, Buffer solution, Mobile phase, Standard stock preparation, and Standard preparation— Proceed as directed in the Assay under Hyoscyamine Sulfate Injection.
Tropic acid solution— Dissolve an accurately weighed quantity of tropic acid in Diluent to obtain a solution having a concentration of about 3 µg of tropic acid per mL.
System suitability preparation— Transfer 3.0 mL of the Standard stock preparation into a 100-mL volumetric flask, add 4.0 mL of the Tropic acid solution, dilute with Diluent, to volume and mix.
Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed quantity of the powder, equivalent to about 0.125 mg of hyoscyamine sulfate, to a 25-mL volumetric flask. Add about 20 mL of the Diluent, and sonicate for 15 minutes with occasional swirling. Allow to cool to room temperature, dilute with Diluent to volume, and mix. Pass an aliquot through a 0.45-µm filter, discarding the first 5 mL of the filtrate.
Chromatographic system— The liquid chromatograph is equipped with a 205-nm detector and a 4.6-mm × 15-cm column that contains 4-µm packing L11 and a 3-mm × 4-mm guard column that contains packing L11. The flow rate is about 1.0 mL per minute. The column temperature is maintained at 30. Chromatograph the System suitability preparation, and record the peak responses as directed for Procedure: the elution order is the tropic acid peak, followed by the hyoscyamine peak; the resolution, R, between tropic acid and hyoscyamine is not less than 1.5; the tailing factor for the hyoscyamine peak is not more than 1.8; and the relative standard deviation for six replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 50 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the area responses for the major peaks. Calculate the quantity, in mg, of hyoscyamine sulfate [(C17H23NO3)2·H2SO4·2H2O] in the portion of Tablets taken by the formula:
25 × 1.053 × C(rU / rS)
in which 1.053 is the ratio of the molecular weight of hydrated hyoscyamine sulfate to that of anhydrous hyoscyamine sulfate; C is as defined under Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Senior Scientist
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
Reference Standards Lili Wang, Technical Services Scientist
701 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 2604
Pharmacopeial Forum: Volume No. 31(5) Page 1374
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.