Malaysian Journal of Analytical Sciences Vol 20 No 2 (2016): 247 - 257

 

 

 

STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ASPIRIN AND CLOPIDOGREL IN DOSAGE FORM

 

(Kestabilan Kaedah KCPT-Indikator bagi Penentuan Serentak Asprin dan Clopidogrel Dalam Bentuk Dos)

 

Md. Gousuddin*, Pinaki Sengupta, Vijaya Datt Tripathi, Arindam Das

 

Faculty of Pharmacy,

Lincoln University College, 47301 Petaling Jaya, Selangor, Malaysia    

 

*Corresponding author: Inamdarirfan09@gmail.com

 

 

Received: 13 June 2015; Accepted: 1 February 2016

 

 

Abstract

Stability-indicating High Performance Liquid Chromatographic (HPLC) method was developed for simultaneous Aspirin and Clopidogrel, A Phenomenex Gemini C-18, 5 µm column having 250mm x 4.6 mm i.d. in isocratic mode, with mobile phase containing buffer  solution 0.3% orthophosphoric acid : acetonitrile (65: 35, v/v). The flow rate was 1 ml/min and effluents were monitored at 266 nm. For linearity seven points calibration curve were obtained in a concentration range from 0.030 –0.120 mg/ml for aspirin and 0.015 – 0.060 mg/ml for clopidogrel with correlation coefficient 0.9999. In the present study stability indicating HPLC method for the combination was tested by degrading the drugs together under various stress conditions like acid hydrolysis, base hydrolysis, oxidation, thermal and photolytic stress which is recommended by ICH guideline.

 

Keywords: reverse phase high performance liquid chromatography, stability indicating method, aspirin, clopidogrel

 

Abstrak

Kestabilan Kaedah Kromatografi Cecair Prestasi Tinggi (KCPT) – indikator telah dibangunkan bagi penentuan serentak Aspirin dan Clopidogrel. Turus Phenomenex Gemini C-18, 250mm x 4.6 mm i.d. diguna dalam mod isokratik, bersama fasa bergerak yang mengandungi larutan penimbal iaitu 0.3% asid orthofosforik : acetonitril. Kadar aliran adalah 1ml/min dan effluent dipantau pada panjang gelombang 266 nm. Tujuh titik lengkung kalibrasi dipilih bagi ujian kelinearan yang diperolehi dari julat 0.030 – 0.120 mg/ml dan 0.015 – 0.060 masing – masing bagi aspirin dan clopidogrel dengan nilai pekali korelasi adalah 0.9999. Dalam kajian ini, kestabilan kaedah KCPT- indikator bagi gabungan analit diuji di bawah pelbagai tekanan seperti hidrolisis asid, hidrolisis bes, pengoksidaan, termal dan tekanan fotolitik seperti yang dicadangkan oleh garis panduan ICH. 

 

Kata kunci: kromatografi cecair prestasi tinggi fasa terbalik, kestabilan kaedah indikator, aspirin, clopidogrel

 

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