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

Shashikant B. Landge; Sanjay A. Jadhav; Sunil B. Dahale; Rajendra S. Shinde; Kunal M. Jagtap; Saroj R. Bembalkar; Vijayavitthal T. Mathad

doi:10.32628/IJSRST1731024

Authors

Shashikant B. Landge Department of Process Research and Development, Megafine Pharma Lakhmapur, Dindori, Nashik, Maharashtra, India
Sanjay A. Jadhav Department of Process Research and Development, Megafine Pharma Lakhmapur, Dindori, Nashik, Maharashtra, India
Sunil B. Dahale Department of Process Research and Development, Megafine Pharma Lakhmapur, Dindori, Nashik, Maharashtra, India
Rajendra S. Shinde Department of Process Research and Development, Megafine Pharma Lakhmapur, Dindori, Nashik, Maharashtra, India
Kunal M. Jagtap Department of Process Research and Development, Megafine Pharma Lakhmapur, Dindori, Nashik, Maharashtra, India
Saroj R. Bembalkar Department of Chemistry, Deogiri College, Aurangabad, Maharashtra, India
Vijayavitthal T. Mathad Department of Process Research and Development, Megafine Pharma Lakhmapur, Dindori, Nashik, Maharashtra, India

Keywords:

Macitentan, Core-Shell HPLC Column, RSD and Validation, Stability Indicating.

Abstract

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.

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