Pilocarpine Hydrochloride Ophthalmic Solution
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.
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.
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 water
Sample solution:
Nominally equivalent to 1.6 mg/mL of pilocarpine hydrochloride from a volume of Ophthalmic Solution diluted with methanol
Chromatographic system
Mode:
LC
Detector:
UV 220 nm
Column:
4.6-mm × 25-cm; packing L3
Flow rate:
2 mL/min
Injection size:
10 µL
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
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 = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Pilocarpine Hydrochloride RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• Sterility Tests 
71
:
Meets the requirements
71:
Meets the requirements
• pH 791:
3.5–5.5
791:
3.5–5.5
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• USP Reference Standards 11
11
USP Pilocarpine Hydrochloride RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Feiwen Mao, M.S.
Senior Scientific Liaison 1-301-816-8320 |
(SM32010) Monographs - Small Molecules 3 |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4323