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LAAN-A-LC-E295

Application High Performance Liquid Chromatography

News
Analysis of Montelukast Sodium Using Prominence-i
and Nexera-i MT
No. L520

Montelukast sodium is used as a therapeutic drug for Table 1 Analytical Conditions
treating bronchial asthma and allergic rhinitis, and is Column : Phenyl silyl silica gel column
listed in the 17th edition of the Japanese (50 mm L. × 4.6 mm I.D., 1.8 μm)
Flow rate : 1.2 mL/min
Pharmacopoeia (JP). The JP is aiming for international Mobile phase : A) Water/Trifluoroacetic acid = 2000/3 (v/v)
harmonization with the US Pharmacopoeia (USP) and B) Acetonitrile/Trifluoroacetic acid = 2000/3 (v/v)
European Pharmacopoeia (EP), and descriptions for Time program : B Conc. 40 % (0 min) → 40 % (3 min) → 51 % (16 min)
this drug have already been harmonized between the Column temp. : 30 °C
Detection : UV 238 nm (Cell temp. 40 °C)
USP and EP. Therefore, the testing methods described Injection vol. : 10 μL
in the JP are based on this harmonized content.
Structural formulae of impurities and flow rates used
for analysis are clearly indicated, showing how the tests 150 mAU
should be from now on.
This article introduces system suitability tests of B
montelukast sodium using Prominence-i and Nexera-i 125 Montelukast Sodium
MT in compliance with the 17th edition of the JP.
K. Nakajima, Y. Osaka
100
 Analysis of Montelukast Sodium Using
Prominence-i 75
A system suitability test was conducted according to
the quantitative method for montelukast sodium 50
(Fig. 1) described in the JP. E
Solution A (1 mg/mL) for peak identification was C, D F
prepared using the montelukast standard for system 25
suitability tests. Solution B for peak identification was Impurity A
then prepared by taking 1 mL of solution A into a clear
vial and allowing to stand it for 20 minutes. Table 1 lists 0
the analytical conditions of solution B. The obtained
chromatogram using Prominence-i is shown in Fig. 2 0.0 2.5 5.0 7.5 10.0 12.5 15.0 min
and indicates that the related substances listed in the
Chromatogram of Montelukast Sodium Standard
JP are also identified. Table 2 shows results of the for System Suitability Test Using Prominence-i
system suitability test.

Table 2 Results of System Suitability Test (Prominence-i)
System Suitability Requirements Results Judgements
Resolution
(Montelukast Sodium ≥ 2.5 3.8 PASSED
and Impurity B)
Resolution
(Montelukast Sodium ≥ 1.5 2.8 PASSED
and Impurity E)
System Repeatability ≤ 0.73 % 0.27 PASSED
(% RSD Area)

Structural Formula of Montelukast Sodium