Pyridoxine Hydrochloride Tablets DEFINITION Pyridoxine Hydrochloride Tablets contain NLT 95.0% and NMT 115.0% of the labeled amount of pyridoxine hydrochloride (C8H11NO3·HCl). IDENTIFICATION • A. Reaction with Ferric Ion Sample: Equivalent to 100 mg of pyridoxine hydrochloride from a quantity of powdered Tablets Analysis: Add 5 mL of water to the Sample. Shake the mixture, filter into a test tube, and add 2 or 3 drops of ferric chloride TS. Acceptance criteria: An orange to deep red color is produced. ASSAY • Procedure Buffer: Dissolve 16 g of ammonium chloride in 70 mL of water, add 16 mL of ammonium hydroxide, dilute with water to 100 mL, and filter. Color reagent: 0.4 mg/mL of 2,6-dichloroquinone chlorimide in isopropyl alcohol. [NoteStore the solution in a refrigerator, and use within one month. Do not use the solution if it has become pink. ] Standard stock solution: 0.1 mg/mL of USP Pyridoxine Hydrochloride RS in 0.1 N hydrochloric acid. [NoteKeep the solution in an amber bottle, in a cool place. ] Standard solution: 10 µg/mL of USP Pyridoxine Hydrochloride RS from the Standard stock solution diluted with water. [NotePrepare this solution daily as needed. ] Sample solution: Weigh and finely powder NLT 20 Tablets. Transfer, with the aid of water, a portion of the powdered Tablets to a conical flask. Add 0.5 mL hydrochloric acid per each mg of the nominal amount of pyridoxine hydrochloride taken, then dilute with water to about 0.04 mg/mL, and heat on a steam bath until disintegration is complete. Cool, dilute with water to 10 µg/mL, and centrifuge a portion of the mixture. Instrumental conditions Mode: Visible Analytical wavelength: 650 nm Blank: Water Analysis Samples: Standard solution and Sample solution Separately add 25.0 mL of isopropyl alcohol to 5 mL each of the Standard solution and the Sample solution. Transfer 5 mL of each of the resulting solutions to separate, glass-stoppered, 25-mL graduated cylinders or test tubes, and add in succession, mixing after each addition, 1.0 mL of Buffer, 1.0 mL of a 0.2-g/mL solution of sodium acetate, and 1.0 mL of water. Cool to 25, add 1.0 mL of Color reagent, and shake vigorously for 10 s, accurately timed. Determine the absorbance 90 s after the addition of the Color reagent. Repeat the procedure both for the Standard solution and the Sample solution, but substitute 1.0 mL of a 50-mg/mL solution of boric acid solution for the 1.0 mL of water. [NoteMake the reading promptly to avoid errors due to fading of the color. ] Calculate the percentage of the labeled amount of pyridoxine hydrochloride (C8H11NO3·HCl) in the portion of Tablets taken: Result = (AU AU¢)/(AS AS¢) × (CS/CU) × 100
Acceptance criteria: 95.0%115.0% PERFORMANCE TESTS • Dissolution, Procedure for a Pooled Sample 711 Medium: Water; 900 mL Apparatus 2: 50 rpm Time: 45 min Mobile phase: A mixture of methanol, glacial acetic acid, and water (27:1:73) containing 1.40 mg/mL of sodium 1-hexanesulfonate Standard solution: Known concentration of USP Pyridoxine Hydrochloride RS in Medium Sample solution: Filtered portion of the solution under test, suitably diluted with Medium if necessary Chromatographic system Mode: LC Detector: UV 280 nm Column: 3.9-mm × 30-cm; packing L1 Flow rate: 1 mL/min Injection size: 10 µL System suitability Sample: Standard solution Suitability requirements Relative standard deviation: NMT 3.0% Analysis Samples: Standard solution and Sample solution Calculate the percentage of the labeled amount of pyridoxine hydrochloride (C8H11NO3·HCl) dissolved: Result = (rU/rS) × (CS × D × V/L) × 100
Tolerances: NLT 75% (Q) of the labeled amount of pyridoxine hydrochloride (C8H11NO3·HCl) is dissolved. • Uniformity of Dosage Units 905: Meet the requirements Content uniformity Standard solution: 10 µg/mL of USP Pyridoxine Hydrochloride RS in dilute hydrochloric acid (1 in 100) Sample solution: Transfer 1 Tablet, finely powdered, to a 500-mL volumetric flask containing 300 mL of water, shake for 30 min, and dilute with water to volume. Filter a portion of the mixture, discarding the first 25 mL of the filtrate. Dilute an aliquot of the filtrate with dilute hydrochloric acid (1 in 100) to obtain 10 µg/mL of pyridoxine hydrochloride. Instrumental conditions Mode: UV Analytical wavelength: 290 nm Cell: 1 cm Blank: Dilute hydrochloric acid (1 in 100) Analysis Samples: Standard solution and Sample solution Determine the absorbances of the Standard solution and Sample solution. Calculate the percentage of pyridoxine hydrochloride (C8H11NO3·HCl) in the portion of Tablets taken: Result = (AU/AS) × (CS/CU) × (100/L)
ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in well-closed containers, protected from light. Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4492 Pharmacopeial Forum: Volume No. 30(1) Page 177 |