Pilocarpine Hydrochloride Ophthalmic Solution
» Pilocarpine Hydrochloride Ophthalmic Solution is a sterile, buffered, aqueous solution of Pilocarpine Hydrochloride. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C11H16N2O2·HCl. It may contain suitable antimicrobial agents and stabilizers, and suitable additives to increase its viscosity.
Packaging and storage— Preserve in tight containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Sterility 71: meets the requirements.
pH 791: between 3.5 and 5.5.
Mobile phase— Mix 300 mL of a 1 in 50 solution of ammonium hydroxide in isopropyl alcohol and 700 mL of n-hexane. Filter through a 0.5-µm filter before using.
Standard preparation— Using an accurately weighed quantity of USP Pilocarpine Hydrochloride RS, prepare a solution having a known concentration of about 1.6 mg per mL.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 80 mg of pilocarpine hydrochloride, to a 50-mL volumetric flask. Dilute with methanol to volume, and mix.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 220-nm detector and a 4.6-mm × 25-cm column that contains packing L3. The flow rate is about 2 mL per minute. Chromatograph three replicate injections of the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation is not more than 2.0%.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph by means of a suitable microsyringe or sampling valve, record the chromatograms, and measure the responses for the major peaks. The retention time is about 16 minutes for pilocarpine hydrochloride. Calculate the quantity, in mg, of C11H16N2O2·HCl in each mL of the Ophthalmic Solution taken by the formula:
50(C / V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Pilocarpine Hydrochloride RS in the Standard preparation, V is the volume, in mL, of Ophthalmic Solution taken, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
(MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3306
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.