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Development and Validation of Stability Indicating RP-HPLC Method on Core Shell Columnfor Determination of Degradation and Process Related Impurities of Macitentan- Anti-hypertension Drug

Authors(7) :-Shashikant B. Landge, Sanjay A. Jadhav, Sunil B. Dahale, Rajendra S. Shinde, Kunal M. Jagtap, Saroj R. Bembalkar, Vijayavitthal T. Mathad

A core shell chromatographic column was used to separate the nine process related and degradation related impurities(Imp-1 to Imp-9) of Macitentanis described in this article. The chromatographic separation was achieved on a Sigma-Aldrich’s ‘Ascentis Express ® C18 (4.6 mm x 100 mm, 2.7 µ)’ HPLC column with a runtime of 35 min. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic, and thermal degradation conditionsto demonstrate the stability-indicating nature of developed RP-HPLC method.The methodology consists of mobile phase-A as aphosphate buffer and mobile phase-B as a mixture of acetonitrile andmethanol. The column oven temperature was set at 45°C, injection thermostat was set at 5°C, and photodiode array detector (PDA) was set at 215 nm.Adeveloped method was validated as per ICH guideline and found rapid, specific,precise, sensitive,androbust. The proposed RP-HPLC method was successfully applied to the analysis of drug substance and drug product of Macitentan.
Shashikant B. Landge, Sanjay A. Jadhav, Sunil B. Dahale, Rajendra S. Shinde, Kunal M. Jagtap, Saroj R. Bembalkar, Vijayavitthal T. Mathad
Macitentan, Core-Shell HPLC Column, RSD and Validation, Stability Indicating.
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Publication Details
  Published in : Volume 3 | Issue 10 | November-December 2017
  Date of Publication : 2017-12-31
License:  This work is licensed under a Creative Commons Attribution 4.0 International License.
Page(s) : 105-117
Manuscript Number : IJSRST1731024
Publisher : Technoscience Academy
PRINT ISSN : 2395-6011
ONLINE ISSN : 2395-602X
Cite This Article :
Shashikant B. Landge, Sanjay A. Jadhav, Sunil B. Dahale, Rajendra S. Shinde, Kunal M. Jagtap, Saroj R. Bembalkar, Vijayavitthal T. Mathad, "Development and Validation of Stability Indicating RP-HPLC Method on Core Shell Columnfor Determination of Degradation and Process Related Impurities of Macitentan- Anti-hypertension Drug ", International Journal of Scientific Research in Science and Technology(IJSRST), Print ISSN : 2395-6011, Online ISSN : 2395-602X, Volume 3, Issue 10, pp.105-117, November-December-2017.
Journal URL : http://ijsrst.com/IJSRST1731024

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