Enalapril Maleate Compounded Oral Suspension, Veterinary

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

Enalapril Maleate Compounded Oral Suspension, Veterinary contains NLT 90.0% and NMT 110.0% of the labeled content of enalapril maleate (C₂₀H₂₈N₂O₅ · C₄H₄O₄)

Prepare Enalapril Maleate Compounded Oral Suspension, Veterinary 10 mg/ml as follows (see Pharmaceutical Compounding-Nonstenile Preparations (795)).

^aPerrigo, Minneapolis, MN.

Pour the Enalapril maleate powder into a suitable container. Wet the powder with a small amount of Ora-Blend, and triturate to make a smooth paste. Add the Ora-Blend to make the mortar conteritis pourable. Transfer the contents of the mortar stepwise and quantitatively to a calibrated container using the Ora-Blend. Add sufficient Ora-Blend to bring the preparation to final volume. Shake to mix well.

2 ASSAY

PROCEDURE

Solution A: Dissolve 2.8 g of monobasic sodium phosphate in 1000 mL of water. Adjust with 1 N sodium hydroxide to a pH of 6.8.

Solution B: Acetonitrile and Solution A (5:95)

Solution C: Acetonitrile and Solution A (66:34)

Solution D: Dissolve 2.8 g g of monobasic sodium phosphate in 1000 ml of of water. ter. Adjust with phosphoric acid to a pH of 2.5.

Diluent: Acetonitrile and Solution D (5:95)

Mobile phase: See Table 1.

Standard solution: 1 mg/mL of USP Enalapril Maleate RS in Diluent

Sample solution: Shake thoroughly each bottle of Oral Suspension. Transfer 1.0 ml of the Oral Suspension into a 10-ml volumetric flask, dilute with Diluent to volume, and mix well to dissolve. Pass through a PVDF filter of 0.45-um pore size, discarding the first 3 mi to waste.

Chromatographic system

(See Chromatography (621) System Suitability)

Mode: LC

Detector: UV 215 nm

Column: 4.6-mm × 25-cm; 5-μm packing L21

Column temperature: 60°

Flow rate: 1.0 mL/min

Injection volume: 10 μL

System suitability

Sample: Standard solution

[NOTE-The retention time for enalapril maleate is about 14.2 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 enalapril maleate (C₂₀H₂₈N₂O₅ · C₄H₄O₄) in the portion of Oral Suspension taken:

Result = (r_U/(r_S) × (C_S /C_U) x 100

r_U = peak response of Enalapril Maleate from the Sample solution

r_S = peak response of Enalapril Maleate from the Standard solution

C_S = concentration of USP Enalapril Maleate RS in the Standard solution (mg/ml)

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

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

pH(791): 2.6-3.6

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE Package in tight, light-resistant containers. Store at 2°-8° or at controlled room temperature. 

LABELING: Label it to indicate that it is to be shaken vigorously immediately before use, and to state the Beyond-Use Date. Label it to state that it is for veterinary use only.

BEYOND-USE DATE: NMT 90 days after the date on which it was compounded when stored at 2"-8"; NMT 60 days when stored at controlled room temperature