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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF APIXABAN AS BULK DRUG

By: Damle, Mrinalini C.
Contributor(s): Waghmare, Swapnil S.
Publisher: M P Innovare Academic Sciences Pvt Ltd 2019Edition: Vol.11(5).Description: 37-42p.Subject(s): PHARMACEUTICSOnline resources: Click here In: International journal of pharmacy and pharmaceutical scienceSummary: Objective : To develop and validate simple, sensitive stability indicating HPTLC (High performance thin layer chromatography) method for apixaban. Method s : The chromatographic separation was performed on aluminium plates precoated with silica gel 60 F 254 Result s: The chromatographic condition shows sharp peak of apixaban at Rf value of 0.38±0. 03. Stress testing was carried out according to international conference on harmonization (ICH)Q1A (R2) guidelines and the method was validated as per ICH Q2(R1) guidelines. The calibration curve was found to be linear in the concentration range of 100 -500 ng/band for apixaban. The limit of detection and quantification was found to be 11.66ng/band and 35.33 ng/band, respectively. using toluen e: ethyl acetate: methanol (3:6:1 v/v/v) as mobile phase followed by densitometric scanning at 279 nm. Conclusio n: A new simple, sensitive, stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of apixaban.
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Objective
:
To develop and validate
simple, sensitive
stability indicating HPTLC (High performance thin layer chromatography) method for
apixaban.
Method
s
:
The chromatographic separation was performed on aluminium plates precoated with silica gel 60 F
254
Result
s:
The chromatographic condition shows sharp peak of apixaban at Rf value of 0.38±0.
03. Stress testing was carried out according to
international conference on harmonization (ICH)Q1A (R2) guidelines and the method was validated as per ICH Q2(R1) guidelines.
The calibration
curve was found to be linear in the concentration range of 100
-500
ng/band for apixaban. The limit of detection and quantification was found to be
11.66ng/band
and
35.33
ng/band, respectively.
using toluen
e:
ethyl acetate:
methanol (3:6:1 v/v/v) as mobile phase followed by densitometric scanning at 279 nm.
Conclusio
n:
A new simple,
sensitive,
stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and
validated for the determination of apixaban.

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