자료실

Sertraline Hydrochloride

관리자 | 2015.02.13 13:49 | 조회 3480

                                                                                   Sertraline Hydrochloride


설명: Click to View Image


C17H17Cl2N·HCl 342.69
1-Naphthalenamine, 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-, hydrochloride, (1S-cis);    
(1S,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride     설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/blank.gif설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/blank.gif설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/blank.gif[79559-97-0].

DEFINITION

Sertraline Hydrochloride contains NLT 97.0% and NMT 102.0% of C17H17Cl2N·HCl, calculated on the anhydrous basis.

IDENTIFICATION

•  A. Infrared Absorption 설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/lang.gif197M설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/rang.gif

•  B. The retention time of the major peak of the Sample solution corresponds to that of sertraline hydrochloride from the System suitability solution, as obtained in the test for Limit of (R,R) sertraline hydrochloride.

•  C. Identification Tests—General, Chloride 설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/lang.gif191설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/rang.gif: Meets the requirements

Sample solution:  A solution (1 in 10) in a mixture of alcohol and water (1:1)

ASSAY

•  Procedure

Buffer:  5.75 g/L of monobasic ammonium phosphate in water. Adjust with phosphoric acid to a pH 4.2.

Mobile phase:  Methanol and Buffer (12:13)

Standard solution:  0.04 mg/mL of USP Sertraline Hydrochloride RS in Mobile phase

Sample solution:  0.04 mg/mL of Sertraline Hydrochloride in Mobile phase

Chromatographic system 

(See Chromatography 설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/lang.gif621설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/rang.gif, System Suitability.)

Mode:  LC

Detector:  UV 220 nm

Column:  4.0-mm × 25-cm; 5-µm packing L45

Column temperature:  30설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/deg.gif

Flow rate:  1 mL/min

Injection size:  20 µL

System suitability 

Sample:  Standard solution

Suitability requirements 

Tailing factor:  NMT 1.3

Relative standard deviation:  NMT 2.0%

Analysis 

Samples:  Standard solution and Sample solution

Calculate the percentage of C17H17Cl2N·HCl in the portion of Sertraline Hydrochloride 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 Sertraline Hydrochloride RS in the Standard solution (mg/mL)

CU

=

= concentration of Sertraline Hydrochloride in the Sample solution (mg/mL)

Acceptance criteria:  97.0%–102.0% on the anydrous basis

IMPURITIES

Inorganic Impurities 

•  Residue on Ignition 설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/lang.gif281설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/rang.gif: NMT 0.3%

•  Heavy Metals, Method II 설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/lang.gif231설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/rang.gif: 30 ppm

SPECIFIC TESTS

•  Water Determination, Method Ia 설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/lang.gif921설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/rang.gif: NMT 0.50%

•  Limit of (R,R) Sertraline Hydrochloride

Mobile phase:  Hexane, 2-propanol, and diethylamine (960:40:1.5)

System suitability solution:  Transfer 10 mg of USP Sertraline Hydrochloride Racemic Mixture RS into a 20-mL volumetric flask. Add 4 mL of diluted ammonia water (1 in 10) and 10 mL of hexane. Shake well until the organic phase is clear. Wait for phase separation, transfer about 2.0 mL from the top layer into a 20-mL volumetric flask, and dilute with hexane to volume.

Standard solution:  Transfer 10 mg of USP Sertraline Hydrochloride RS into a 20-mL volumetric flask. Add 4 mL of diluted ammonia water (1 in 10) and 10 mL of hexane. Shake well until the organic phase is clear. Wait for phase separation, transfer 1.0 mL from the top layer into a 10-mL volumetric flask, and dilute with hexane to volume. Further dilute quantitatively and stepwise, if necessary, to obtain a solution having a known concentration of 0.01 mg/mL.

Sample solution:  Transfer 20 mg of Sertraline Hydrochloride to a 20-mL volumetric flask. Add 4 mL of diluted ammonia water (1 in 10) and 10 mL of hexane. Shake well until the organic phase is clear. Wait for phase separation, and use the top layer.

Chromatographic system 

(See Chromatography 설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/lang.gif621설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/rang.gif, System Suitability.)

Mode:  LC

Detector:  UV 235 nm

Column:  4.6-mm × 25-cm; 5-µm packing L40

Column temperature:  5설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/deg.gif

Flow rate:  1 mL/min

Injection size:  20 µL

System suitability 

Sample:  System suitability solution

[Note—The relative retention times for (R,R) sertraline hydrochloride and sertraline hydrochloride are about 1.16 and 1.0, respectively. ]

Suitability requirements 

Resolution:  NLT 2.8 between sertraline hydrochloride and (R,R) sertraline hydrochloride

Relative standard deviation:  NMT 10.0%

Analysis 

Samples:  Standard solution and Sample solution

Calculate the percentage of (R,R) sertraline hydrochloride in the portion of Sertraline Hydrochloride taken:

Result = (rU/rS) × (CS/CU) × 100

rU

=

= peak response for (R,R) sertraline hydrochloride from the Sample solution

rS

=

= peak response for Sertraline Hydrochloride from the Standard solution

CS

=

= concentration of USP Sertraline Hydrochloride RS in the Standard solution (mg/mL)

CU

=

= concentration of Sertraline Hydrochloride in the Sample solution (mg/mL)

Acceptance criteria:  NMT 1.5%

ADDITIONAL REQUIREMENTS

•  Packaging and Storage: Preserve in tight, light-resistant containers at a temperature not exceeding 40설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/deg.gif.

•  USP Reference Standards 설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/lang.gif11설명: http://www.drugfuture.com/pharmacopoeia/usp35/images/chars/rang.gif

USP Sertraline Hydrochloride RS 설명: Click to View Structure

USP Sertraline Hydrochloride Racemic Mixture RS
(1RS,4RS)-4-(3,4-Dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthylamine hydrochloride.
    C17H17CI2·HCI        342.69

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question

Contact

Expert Committee

Monograph

Hariram Ramanathan, M.S.
Associate Scientific Liaison
1-301-816-8313

(SM42010) Monographs - Small Molecules 4

Reference Standards

RS Technical Services
1-301-816-8129
rstech@usp.org

USP35–NF30 Page 4629

Pharmacopeial Forum: Volume No. 34(5) Page 1189

twitter facebook me2day 요즘