Fluticasone Pressurised Inhalation BP 2022

Fluticasone Pressurised Inhalation - British Pharmacopoeia https://www.pharmacopoeia.com/bp-2022/formulated-specific/fluticaso...
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Pressurised Inhalation
General Notices
Action and use
Glucocorticoid.
DEFINITION
Pressurised Inhalation is a suspension of Propionate in a suitable liquid in a pressurised container fitted with a
metering dose valve.
PRODUCTION
The size of aerosol particles to be inhaled is controlled so that a consistent portion is deposited in the lung. The fine-particle
characteristics of pressurised metered-dose preparations for inhalation are determined using the method described in Appendix XII C.
7. Preparations for Inhalation: Aerodynamic Assessment of Fine Particles.
Content of propionate, C25H31F3O5S
80.0 to 120.0% of the stated amount.
IDENTIFICATION
A. The , Appendix II B, in the range 210 to 300 nm of the final solution obtained in the test for Uniformity of delivered
dose closely resembles that of a solution containing 0.0005% w/v of in solvent A and exhibits a single
maximum at 240 nm.

B. In the test for Uniformity of delivered dose, the retention time of the principal peak in the chromatogram obtained with solution (1) is
similar to that of the principal peak in the chromatogram obtained with solution (2).
TESTS
Related substances
Carry out the method for , Appendix III D, using the following solutions.
(1) Shake a quantity of the pressurised inhalation containing 0.5 mg of Propionate in 10 mL of a mixture of 7 volumes of
, 20 volumes of and 23 volumes of and filter.
(2) Dilute 1 volume of solution (1) to 200 volumes in equal volumes of and .
1 of 3 12/22/2022, 1:39 PM
(3) 0.02% w/v of and 0.00004% w/v of S in equal volumes of

and .
(4) Dilute 1 volume of solution (2) to 5 volumes in equal volumes of and .
CHROMATOGRAPHIC CONDITIONS
(a) Use a stainless steel column (25 cm × 4.6 mm) packed with (5 µm) (Spherisorb ODS1
is suitable).
(b) Use gradient elution and the mobile phase described below.
(c) Use a flow rate of 1.5 mL per minute.
(d) Use a column temperature of 40°.

(e) Use a detection wavelength of 239 nm.
(f) Inject 20 µL of each solution.
MOBILE PHASE
23 volumes of and 77 volumes of .
0.01M adjusted to pH 3.5 with or .
Equilibrate the column with a mobile phase ratio A:B of 60:40. Inject solutions (1) and (3) and start the elution isocratically with the
chosen mobile phase. One minute after elution of the apex of the propionate peak start a linear gradient elution to reach a
mobile phase ratio A:B of 85:15 over a period of 10 minutes. Continue the chromatography for 10 minutes.
SYSTEM SUITABILITY
The test is not valid unless, in the chromatogram obtained with solution (3), the between the peaks due to
propionate and -methyl impurity is at least 1.5.
LIMITS
In the chromatogram obtained with solution (1):
the area of any is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);
the sum of the areas of any is not greater than 5 times the area of the principal peak in the chromatogram obtained
with solution (2) (2.5%).
Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%).
Uniformity of delivered dose
Complies with the requirements stated under Pressurised Metered-dose Preparations for Inhalation using the following method of
analysis. Carry out the method for , Appendix III D, using the following solutions in a mixture of 35 volumes of
add 65 volumes of (solvent A).
(1) Collect single doses of the preparation being examined using the procedure described under Pressurised Metered-dose
Preparations for Inhalation, Uniformity of delivered dose and dissolve the collected dose in sufficient of solvent A to produce a solution
2 of 3 12/22/2022, 1:39 PM
expected to contain 0.0005% w/v of Propionate.

(2) 0.0005% w/v of in solvent A.
CHROMATOGRAPHIC CONDITIONS
(a) Use a stainless steel column (25 cm × 4.6 mm) packed with (5 µm) (Spherisorb ODS1
is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1.5 mL per minute.
(d) Use a column temperature of 40°.
(e) Use a detection wavelength of 239 nm.

(f) Inject 20 µL of each solution.
MOBILE PHASE
15 volumes of 35 volumes of 0.01M and 50 volumes of adjusted to pH 3.5
with or .
SYSTEM SUITABILITY
The test is not valid unless, in the chromatogram obtained with solution (2), the of the principal peak is not greater than
2.5.
DETERMINATION OF CONTENT
Calculate the content of Propionate, C25 H31F3 O5S, per delivered dose using the declared content of C25 H31F3 O5S in
. Repeat the procedure as described under Pressurised Metered-dose Preparations for Inhalation,
Uniformity of delivered dose.
ASSAY
Use the average of the individual results obtained in the test for Uniformity of delivered dose.
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Fluticasone Pressurised Inhalation - British Pharmacopoeia https://www.pharmacopoeia.com/bp-2022/formulated-specific/fluticaso...

Status: You are viewing the legally effective version.

Action and use

metering dose valve.

Content of propionate, C25H31F3O5S

80.0 to 120.0% of the stated amount.

maximum at 240 nm.

, 20 volumes of and 23 volumes of and filter.

(2) Dilute 1 volume of solution (1) to 200 volumes in equal volumes of and .

(3) 0.02% w/v of and 0.00004% w/v of S in equal volumes of

(d) Use a column temperature of 40°.

23 volumes of and 77 volumes of .

0.01M adjusted to pH 3.5 with or .

In the chromatogram obtained with solution (1):

with solution (2) (2.5%).

Uniformity of delivered dose

add 65 volumes of (solvent A).

expected to contain 0.0005% w/v of Propionate.

(e) Use a detection wavelength of 239 nm.

15 volumes of 35 volumes of 0.01M and 50 volumes of adjusted to pH 3.5

© Crown Copyright 2021

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