Clonidine Hydrochloride 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

Clonidine Hydrochloride Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of clonidine hydrochloride (C₉H₉Cl₂N₃ · HCl).

Prepare Clonidine Hydrochloride Compounded Oral Suspension 0.01 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).

^a Clonidine Hydrochloride 0.2-mg tablets, Qualitest, Huntsville, AL

^b Perrigo, Allegan, MI.

Place the Clonidine Hydrochloride Tablets in a suitable container and triturate to a fine powder. Add a small amount of Ora-Blend and mix well to form a smooth paste. Add a sufficient amount of Ora-Blend to make the mortar contents pourable. Transfer contents stepwise and quantitatively to a calibrated container using the remainder of the Ora-Blend. Add sufficient Ora-Blend to bring to final volume. Shake to mix well.

2 ASSAY

2.1 PROCEDURE

Solution A: 10 mM of monobasic potassium phosphate adjusted with 6 N potassium hydroxide to a pH of 8.0

Mobile phase: See Table 1.

           Table 1

Standard stock solution: 0.1 mg/mL of USP Clonidine Hydrochloride RS in water

Standard solution: Transfer 0.5 mL of the Standard stock solution to a 50-mL volumetric flask and dilute with water to volume.

Sample solution: Transfer 1.0 mL of Oral Suspension into a 10-ml volumetric flask and dilute with water to volume.

Chromatographic systemMode: LC

Detector: UV 210 nm

Column: 4.6-mm x 25-cm; 5-µm packing 196

Column temperature: 30°

Flow rate: 1.0 mL/min

Injection volume: 100 µL

2.2 System suitability

Sample: Standard solution

[NOTE-The retention time for clonidine hydrochloride is about 71.3 min.]

2.3 Suitability requirements

Tailing factor: NMT 3.0

Relative standard deviation: NMT 2.0% for replicate injections.

2.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of clonidine hydrochloride (C₉H₉Cl₂N₃ · HCl) in the portion of Oral Suspension taken:

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

r_U = peak response of clonidine hydrochloride from the Sample solution

r_S = peak response of clonidine hydrochloride from the Standard solution s

C_S = concentration of USP Clonidine Hydrochloride RS in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

PH (791): 4.0-5.0

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Package in tight, light-resistant containers. Store at controlled room temperature or in a refrigerator.

BEYOND-USE DATE: NMT 14 days after the date on which it was compounded when stored at controlled room temperature. NMT 90 days after the date on which it was compounded when stored in a refrigerator

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

• USP Reference Standards 〈11〉

USP Clonidine Hydrochloride RS

(USP 1-May-2020)