Simultaneous quantitation of aspirin, amlodipine and simvastatin in a fixed dose combination of encapsulated tablet formulation by HPLC-UV method

Journal Title: Pakistan Journal of Pharmaceutical Sciences - Year 2014, Vol 27, Issue 5

Abstract

 A high-pressure liquid chromatography (HPLC-UV) based simple and specific method for simultaneous quantitative determination of aspirin, amlodipine besylate and simvastatin in a capsule formulation has been developed and validated according to ICH guidelines. Chromatographic separation of the three drugs was carried out by aSpherisorbODS2 reverse phase column (4.6 x 250 mm; 5 µm) using amobile phase, which consisted of 70: 30 (v/v) mixture of acetonitrile and triethylamine phosphate buffer (pH 3; 0.015 M) with final pH adjusted to 2.5 using dilute ortho-phosphoric acid, at a flow rate of 1mL/min. The eluents were detected at UV wavelength of 237 nm and the retention times for aspirin, amlodipine besylate and simvastatin were ~2.7 mins, ~6.1 mins and ~10.5mins, respectively. This method is suitable and specific for the three drugs and was found to be linear (R2>0.995), accurate, specific, reproducible and robust in the concentration range of 375 to 1125mcg/ml for aspirin, 25 to 75mcg/ml for amlodipine besylate and 50 to 150mcg/ml for simvastatin. This simple and convenient method could be easily utilized for the characterization and quantitation of the three drugs in a single formulation for combination therapy of cardiovascular diseases.

Authors and Affiliations

Faisal Sultan , Muhammad Harris Shoaib , Rabia Ismail Yousuf , Farrukh Rafiq Ahmed , Faseeh A Salam , Muhammad Iqbal Nasiri , Muhammad Atif Khan , Saeed Manzoor

Keywords

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  • EP ID EP126865
  • DOI -
  • Views 119
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How To Cite

Faisal Sultan, Muhammad Harris Shoaib, Rabia Ismail Yousuf, Farrukh Rafiq Ahmed, Faseeh A Salam, Muhammad Iqbal Nasiri, Muhammad Atif Khan, Saeed Manzoor (2014).  Simultaneous quantitation of aspirin, amlodipine and simvastatin in a fixed dose combination of encapsulated tablet formulation by HPLC-UV method. Pakistan Journal of Pharmaceutical Sciences, 27(5), 1553-1558. https://www.europub.co.uk/articles/-A-126865