Molindone Hydrochloride Tablets
» Molindone Hydrochloride Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of molindone hydrochloride (C16H24N2O2·HCl).
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
Identification Dissolve a portion of finely powdered Tablets in methanol to obtain a test solution containing about 2.5 mg of molindone hydrochloride per mL. Separately apply 5 µL of the test solution and 5 µL of a Standard solution of USP Molindone Hydrochloride RS in methanol containing 2.5 mg per mL to a thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, protect the chromatogram from light, and develop in a solvent system consisting of a mixture of alcohol and 1 N hydrochloric acid (95:5). Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by spraying with Dragendorff's reagent, prepared as directed for Visualization Technique 3 under Ordinary Impurities 466: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
Uniformity of dosage units 905: meet the requirements.
Medium: 0.1 N hydrochloric acid; 900 mL.
Apparatus 1: 100 rpm.
Time: 30 minutes.
Solvent A Mix 300 mL of methanol and 700 mL of 0.1 N hydrochloric acid.
Solvent B Mix 75 mL of methanol and 25 mL of 0.1 N hydrochloric acid.
Standard solution Transfer about 100 mg of USP Molindone Hydrochloride RS, accurately weighed, to a 250-mL volumetric flask, and dissolve in and dilute with Solvent A to volume. Pipet 5.0 mL of this stock solution into a 250-mL volumetric flask, and dilute with Solvent A to volume. Pipet 15.0 mL of the diluted stock solution into a 50-mL volumetric flask, and dilute with Solvent A to volume.
Test solution Withdraw a portion of the solution under test, and filter, discarding the first 3 mL of filtrate. Pipet 15.0 mL of this solution into a 25-mL volumetric flask, and dilute with Solvent B to volume.
Mobile phase Dissolve 1.08 g of sodium 1-octanesulfonate in 480 mL of water. Add 520 mL of methanol, 2.0 mL of acetic acid, and 0.4 mL of triethylamine, and mix. Make adjustments if necessary (see System Suitability under Chromatography 621).
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 254-nm UV detector and a 4.6-mm × 25-cm column that contains packing L11. The flow rate is about 1.5 mL per minute.
Procedure Separately inject equal volumes (about 100 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the peak heights. Determine the amount of molindone hydrochloride (C16H24N2O2·HCl) dissolved.
Tolerances Not less than 80% (Q) of the labeled amount of C16H24N2O2·HCl is dissolved in 30 minutes.
Mobile phase , Solvent mixture, Internal standard solution, Standard preparation, and Chromatographic systemProceed as directed in the Assay under Molindone Hydrochloride.
Assay preparation Accurately weigh not less than 20 Tablets, grind the Tablets to a homogeneous mixture, and transfer an accurately weighed portion, equivalent to about 50 mg of molindone hydrochloride, to a 250-mL conical flask. Add 10.0 mL of Internal standard solution and 90.0 mL of Solvent mixture, shake for 30 minutes, and filter.
Procedure Proceed as directed for Procedure in the Assay under Molindone Hydrochloride. Calculate the quantity, in mg, of molindone hydrochloride (C16H24N2O2·HCl) in the portion of Tablets taken by the formula:
100C(RU / RS)in which C is the concentration, in mg per mL, of USP Molindone Hydrochloride RS in the Standard preparation, and RU and RS are the ratios of the peak response of molindone to that of butylparaben obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 3942