Cyclopentolate Hydrochloride

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

Cyclopentolate Hydrochloride contains NLT 98.0% and NMT 102.0% of cyclopentolate hydrochloride (C₁₇H₂₅NO₃ . HCI), calculated on the dried basis.

2 IDENTIFICATION

Change to read:

2.1 A.

SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K (CN) 1-MAY-2020)

2.2 B.

The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

2.3 C.

IDENTIFICATION TESTS-GENERAL (191), Chemical Identification Tests, Chloride

Sample solution: 2 mg/mL

Acceptance criteria: Meets the requirements

3 ASSAY

3.1 PROCEDURE

Buffer solution: Dissolve 660 mg of dibasic ammonium phosphate in 1000 mL of water. Adjust with phosphoric acid to a pH of 3.0 ± 0.1.

Mobile phase: Acetonitrile and Buffer solution (7:3)

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

Sample solution: 0.1 mg/mL of Cyclopentolate Hydrochloride in water

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 220 nm

Column: 4.6-mm x 15-cm; 5-µm packing 115

Flow rate: 2 mL/min

Injection volume: 20 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

ples: Standard solution and Sample solution

alculate the percentage of cyclopentolate hydrochloride (C₁₂H₂5NO3 HCI) in the portion of Cyclopentolate Hydrochloride taken: 

Result = (r_u/r_s) × (C_s/C_u) × 100

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution 

C_s = concentration of USP Cyclopentolate Hydrochloride RS in the Standard solution (mg/mL)

C_u = concentration of Cyclopentolate Hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 98.0%-102.0% on the dried basis

4 IMPURITIES

4.1 RESIDUE ON IGNITION (281): NMT 0.05%

4.2 ORGANIC IMPURITIES

Buffer solution, Mobile phase, Standard solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed

in the Assay, except for the Run time.

Run time: NLT twice the retention time of cyclopentolate

Analysis

Sample: Sample solution

Calculate the percentage of each impurity in the portion of Cyclopentolate Hydrochloride taken:

Result = (r_u/r_s) × 100

r_u = peak response of each impurity from the Sample solution

r_s = sum of the responses of all of the peaks, excluding the solvent peak, from the Sample solution

Aceptance criteria

Individual impurity: NMT 1.0%

Total impurities: NMT 2.0%

5 SPECIFIC TESTS

5.1 PH (791).

Sample solution: 10 mg/mL

Acceptance criteria: 4.5-5.5

5.2 LOSS ON DRYING (731)

Sample: Dry at 105° for 4 h.

Acceptance criteria: NMT 0.5%

6 ADDITIONAL REQUIREMENTS

6.1 PACKAGING AND STORAGE:

Preserve in tight containers, and store in a cold place.

6.2 USP REFERENCE STANDARDS (11).

USP Cyclopentolate Hydrochloride RS