Loratadine Oral Solution
Loratadine Oral Solution contains NLT 94.0% and NMT 105.0% of the labeled amount of loratadine (C22H23ClN2O2).
• A. Thin-Layer Chromatographic Identification Test 201
Standard solution: 5 mg/mL of USP Loratadine RS in dichloromethane
Sample solution: Place a volume of Oral Solution, equivalent to 10 mg of loratadine, in a centrifuge tube. Add 10 mL of 0.2 N sodium hydroxide and 2.0 mL of dichloromethane. Rotate the centrifuge tube for 10 min, centrifuge, and discard the aqueous phase.
Developing solvent system: Ethyl ether and diethylamine (40:1), in a paper-lined tank
Acceptance criteria: Meets the requirements
• B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Buffer: 6.8 g/L of monobasic potassium phosphate in water, adjusted with phosphoric acid to a pH of 3.0 ± 0.1
Mobile phase: Acetonitrile and Buffer (3:7)
Diluent: Acetonitrile and water (3:7)
Internal standard solution: 0.3 mg/mL of butylparaben in Diluent
Standard stock solution: 1.0 mg/mL of USP Loratadine RS in acetonitrile
Standard solution: Transfer 5.0 mL of Internal standard solution, 5.0 mL of Standard stock solution, and 12 mL of water to a 50-mL volumetric flask. Dilute with Diluent to volume.
Sample solution: Transfer a portion of Oral Solution, nominally equivalent to 5 mg of loratadine, to a 50-mL volumetric flask. Pipet 5.0 mL of Internal standard solution into the flask, and dilute with Diluent to volume.
Detector: UV 254 nm
Column: 4-mm × 30-cm; 10-µm packing L11
Column temperature: 2030
Flow rate: 2 mL/min
Injection size: 10 µL
Sample: Standard solution
[NoteThe relative retention times for butylparaben and loratadine are about 0.78 and 1.0, respectively. ]
Resolution: NLT 1.9 between loratadine and butylparaben
Tailing factor: NMT 1.6 for the loratadine and butylparaben peaks
Relative standard deviation: NMT 2%
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of loratadine (C22H23ClN2O2) in the portion of Oral Solution taken:
Result = (RU/RS) × (CS/CU) × 100
Acceptance criteria: 94.0%105.0%
• Deliverable Volume 698: Meets the requirements
• Organic Impurities
Mobile phase: 4.3 g/L of sodium dodecyl sulfate in a mixture of acetonitrile and water (1:1). Adjust with phosphoric acid to a pH of 2.6 ± 0.1.
Diluent: Mobile phase and water (2:1)
System suitability solution 1: 2 µg/mL of USP Loratadine RS in Diluent
System suitability solution 2: 0.2 µg/mL of USP Loratadine RS in Diluent from System suitability solution 1
System suitability solution 3: Transfer an amount of Oral Solution, equivalent to 20 mg of loratadine, into a screw-cap glass container. Add 1 mL of 3% aqueous hydrogen peroxide, and mix. Cap, and heat at 65 for 1824 h. Allow to cool to room temperature, and then dilute 5 mL with Diluent to 25 mL.
Sample solution: 0.2 mg/mL of loratadine from a volume of Oral Solution in Diluent
Detector: UV 254 nm
Column: 4.6-mm × 25-cm; 5-µm packing L7
Column temperature: 3040
Flow rate: 2 mL/min
Injection size: 50 µL
Samples: System suitability solution 1, System suitability solution 2, and System suitability solution 3
[NoteSee Table 1 for relative retention times. ]
Resolution: NLT 3.0 between loratadine and 2-hydroxymethyl loratadine, System suitability solution 3
Tailing factor: 0.71.1, System suitability solution 1
Relative standard deviation: NMT 10%, System suitability solution 2
Sample: Sample solution
Calculate the percentage of each individual related compound in the portion of Oral Solution taken:
Result = (rU/rT) × 100
• Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62: The total aerobic microbial count is NMT 102 cfu/mL, and the total combined molds and yeasts count is NMT 5 × 101 cfu/mL. It meets the requirements for the absence of Salmonella species and Escherichia coli.
Change to read:• pH 791: 2.2(RB 1-May-2011)3.1
• Packaging and Storage: Preserve in tight containers, and store between 2 and 25.
• USP Reference Standards 11
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USP35NF30 Page 3713Pharmacopeial Forum: Volume No. 31(1) Page 56