Travoprost Ophthalmic Solution
DEFINITION
Travoprost Ophthalmic Solution is a sterile buffered aqueous solution of Travoprost. It contains NLT 90.0% and NMT 110.0% of the labeled amount of travoprost (C26H35F3O6). It may contain suitable stabilizers, buffers, and antimicrobial agents.
[Caution—Great care should be taken when handling the active ingredient to avoid contact with the body.
]
IDENTIFICATION
• 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
Buffer:
2.18 mg/mL of sodium 1-octanesulfonate in water. Adjust with phosphoric acid to a pH of 3.5.
Mobile phase:
Acetonitrile and Buffer (17:33)
Standard solution:
0.04 mg/mL of travoprost from USP Travoprost RS in a mixture of acetonitrile and water (3:7)
Sample solution:
Use the Ophthalmic Solution without dilution.
Chromatographic system
Mode:
LC
Detector:
UV 220 nm
Column:
4.6-mm × 15-cm; packing L1
Flow rate:
2.0 mL/min
Injection size:
100 µL
System suitability
Sample:
Standard solution
[Note—USP Travoprost RS contains a small percentage of the 5,6-trans isomer. The relative retention times for travoprost and the 5,6-trans isomer are 1.0 and 1.1, respectively. ]
Suitability requirements
Resolution:
NLT 1.5 between travoprost and the 5,6-trans isomer
Column efficiency:
NLT 2000 theoretical plates
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C26H35F3O6 in the portion 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 travoprost in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of travoprost in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
IMPURITIES
Organic Impurities
• Procedure 1: Limit of Travoprost Related Compound A
Buffer:
Add 1.0 mL of phosphoric acid to 1.0 L of water, and adjust with sodium hydroxide to a pH of 3.0.
Mobile phase:
Acetonitrile and Buffer (6:19)
Standard solution:
0.3 µg/mL of USP Travoprost Related Compound A RS in a mixture of acetonitrile and water (1:4)
Sample solution:
Use the Ophthalmic Solution without dilution.
Chromatographic system
Mode:
LC
Detector:
UV 220 nm
Column:
4.6-mm × 5-cm; packing L1
Flow rate:
3.0 mL/min
Injection size:
100 µL
System suitability
Sample:
Standard solution
Suitability requirements
Column efficiency:
NLT 2000 theoretical plates
Relative standard deviation:
NMT 10.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of travoprost related compound A in the portion 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 Travoprost Related Compound A RS in the Standard solution (mg/mL) |
| CU | = | = concentration of travoprost in the Sample solution (mg/mL) |
Acceptance criteria
Travoprost related compound A:
NMT 0.2%
• Procedure 2: Limit of Degradation Products
Buffer, Mobile phase, Standard solution, Sample solution, Chromatographic system, and System suitability:
Prepare as directed in the Assay.
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of each degradation product in the portion of Ophthalmic Solution taken:
Result = (rU/rS) × (CS/CU) × (1/F) × 100
| rU | = | = peak response of each degradation product from the Sample solution |
| rS | = | = peak response of travoprost from the Standard solution |
| CS | = | = concentration of USP Travoprost RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of travoprost in the Sample solution (mg/mL) |
| F | = | = relative response factor (see Impurity Table 1) |
Acceptance criteria
Degradation products:
See Impurity Table 1.
Total impurities:
NMT 5.5%. [Note—Sum of all degradation products, including travoprost related compound A, obtained in Procedure 1. ]
Impurity Table 1
| Name | Relative Retention Time |
Relative Response Factor |
Acceptance Criteria, NMT (%) |
|---|---|---|---|
| 5,6-trans Isomer | 1.1 | 1.0 | 5.0 |
| 15-keto Derivative | 1.4 | 1.7 | 0.3 |
SPECIFIC TESTS
• Sterility Tests 
71
:
Meets the requirements when tested as directed under Test for Sterility of the Product to Be Examined, Membrane Filtration
71:
Meets the requirements when tested as directed under Test for Sterility of the Product to Be Examined, Membrane Filtration
• pH 791:
5.5–6.5
791:
5.5–6.5
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers. Store between 2
and 25.
and 25.
• USP Reference Standards 11
11
USP Travoprost RS 
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USP Travoprost Related Compound A RS
(5Z,13E)-(9S,11R,15R)-9,11,15-Trihydroxy-16-(m-trifluoromethylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid.
C23H29F3O6 458.52
(5Z,13E)-(9S,11R,15R)-9,11,15-Trihydroxy-16-(m-trifluoromethylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid.
C23H29F3O6 458.52
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 4916
Pharmacopeial Forum: Volume No. 32(4) Page 1118