Lansoprazole Compounded Oral Suspension

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

Lansoprazole Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of lansoprazole (C₁₆H₁₆F₃N₃O₂S).

Prepare Lansoprazole Compounded Oral Suspension 3 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).

^a Lansoprazole 30-mg delayed-release capsules, Dr. Reddy's Laboratory Limited, Bridgewater, NJ.

^b Perrigo Pharmaceuticals, Allegan, MI.

Empty the required number of delayed-release capsules, and pour the contents into a mortar or other suitable container. If necessary, crush the contents into a fine powder by using a pestle or other mechanical means. Wet the powder with a small amount of Vehicle, and triturate to make a smooth paste. Add Vehicle to make the mortar contents pourable. Transfer the contents stepwise and quantitatively to a calibrated container using the remainder of Vehicle. Add suficient Vehicle to bring to final volume. Shake to mix well.

Alternatively, a compounded 8.4% sodium bicarbonate solution may be used instead of Sodium Bicarbonate Injection (8.4%). Prepare an 8.4% sodium bicarbonate solution by dissolving 8.4 g of Sodium Bicarbonate in suficient Purified Water to make 100 mL.

2 ASSAY

Procedure

Solution A: 10 mM sodium phosphate adjusted with sodium hydroxide to a pH of 7.5. Pass through a nylon filter of 0.45-μm pore size, and degas.

Solution B: Acetonitrile and water (50:50)

Solution C: Water adjusted with 1 M sodium hydroxide to a pH of 6.5

Mobile phase: Acetonitrile and Solution A (45:55)

Standard stock solution: 3 mg/mL of USP Lansoprazole RS in Solution B. Mix well, and sonicate for 3 min. Store at 2°–8°.

Standard solution: Transfer 2.0 mL of the Standard stock solution to a 500-mL volumetric flask, and dilute with Solution C to volume.

Centrifuge an aliquot of the solution for 5 min at 14,000 rpm, and use the supernatant. Protect from light, and store at 2°–8°.

Sample solution: Shake each bottle of Oral Suspension thoroughly. Transfer 2.0 mL of Oral Suspension to a 500-mL volumetric flask, and dilute with Solution C to volume. Centrifuge an aliquot of the solution for 5 min at 14,000 rpm, and use the supernatant. Protect from light, and store at 2°–8°.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 285 nm

Column: 4.6-mm × 25-cm; 5-μm packing L1

Temperatures

Column: 35°

Autosampler: 5°

Flow rate: 1.0 mL/min

Injection volume: 20 μL

System suitability

Sample: Standard solution

[Note—The retention time for lansoprazole is about 5.2 min.]

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of lansoprazole (C₁₆H₁₆F₃N₃O₂S) in the portion of Oral Suspension taken:

Result = (r_U/r_S)x(C_S/C_U) × 100

r_U = peak response of lansoprazole from the Sample solution

r_S = peak response of lansoprazole from the Standard solution

C_S = concentration of lansoprazole in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 8.0–8.5

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant containers. Store at 2°–8° or at controlled room temperature.

Labeling: Label Oral Suspension to indicate that it is to be well shaken before use, and to state the Beyond-Use Date.

Beyond-Use Date: NMT 90 days after the date on which it was compounded, when stored at 2°–8° or at controlled room temperature

USP Reference Standards 〈11〉

USP Lansoprazole RS