Pilocarpine Hydrochloride Ophthalmic Solution

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

Pilocarpine Hydrochloride Ophthalmic Solution is a sterile, buffered, aqueous solution of pilocarpine hydrochloride. It contains NLT 90.0% and NMT 110.0% of the labeled amount of pilocarpine hydrochloride (C₁₁H₁₆N₂O₂ · HCl). It may contain suitable antimicrobial agents and stabilizers, and suitable additives to increase its viscosity.

2 IDENTIFICATION

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

3 ASSAY

Procedure

Solution A: Ammonium hydroxide in isopropyl alcohol (1 in 50)

Mobile phase: n-Hexane and Solution A (700:300)

Standard solution: 1.6 mg/mL of USP Pilocarpine Hydrochloride RS in methanol

Sample solution: Nominally equivalent to 1.6 mg/mL of pilocarpine hydrochloride from a volume of Ophthalmic Solution diluted with methanol

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 220 nm

Column: 4.6-mm × 25-cm; packing L3

Flow rate: 2 mL/min

Injection size: 10 µL

3.2 System suitability

Sample: Standard solution

[Note—The retention time for pilocarpine hydrochloride is 16 min.]

Suitability requirements

Relative standard deviation: NMT 2.0% for pilocarpine hydrochloride for three replicate injections

3.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of pilocarpine hydrochloride (C₁₁H₁₆N₂O₂ · HCl) in each mL of Ophthalmic Solution taken:

Result = (r_U /r_S) × (C /C_U ) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

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

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

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

Sterility Tests 〈71〉: Meets the requirements

pH 〈791〉: 3.5–5.5

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Pilocarpine Hydrochloride RS