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A New Reverse-Phase High Performance Liquid Chromatography Method for Simultaneous Estimation of Fimasartan, Rosuvastatin Calcium, and Amlodipine Besylate in Combination

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Pharmaceutical Chemistry Journal Aims and scope

A reverse-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for simultaneous estimation of fimasartan (FIM), amlodipine besylate (AML) and rosuvastatin calcium (ROS) in combination for the treatment of hypertension with dyslipidemia presenting a major risk factor for cardiovascular diseases. Chromatographic separation was performed on stationary reverse-phase inert sustain-swift C18 100A° (250 mm × 4.6 mm, 5 μm i.d.) column. The optimized mobile phase acetonitrile – methanol – water (15:15:70, v/v, at pH 3.5 adjusted with 0.1% ortho-phosphoric acid) was pumped at a flow rate of 1.0 mL/min and the effluent spectrum was monitored at 230 nm. Calibration graphs of drugs constructed at their wavelengths of determination were linear in a concentration range of 10 – 100 μg/mL for all three components. The retention times for FIM, ROS calcium, and AML peaks at 230 nm were found to be 4.6, 6.4, and 10.8 min respectively. The method suggested usefulness of a unique mobile phase during the estimation of two or more multicomponent dosage forms. Due to its simplicity, rapidness, high precision, and accuracy, the proposed RP-HPLC method can be applied for simultaneous determination of FIM, ROS and AML in bulk mixture.

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Acknowledgements

The authors are thankful to Glenmark Pharmaceuticals Ltd., Alkem Laboratories, and Chandra Labs Ltd. (India) for providing reference standards and to Laxminarayan Dev College of Pharmacy for providing all facilities to complete this research work.

CONFLICT OF INTEREST

The authors declare that they have no conflicts of interest.

AUTHOR CONTRIBUTIONS

All authors have equally contributed to this work.

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Authors and Affiliations

  1. Shri Jagdishprasad Jhabarmal Tibrewala University, Vidyanagari, Jhunjhunu, Rajasthan, 333001, India

    Rujuta Prashant Mistry

  2. Department of Pharmaceutical Science, Sigma Institute of Pharmacy, Vadodara, India

    Chainesh Shah

  3. Department of Pharmacy, Shree Jagdish Prashad Jablamer Tiberwala University, Rajasthan, India

    Rakesh Jat

  4. Department of Pharmacy, Laxminarayan Dev College of Pharmacy, Bharuch, India

    Rakesh Jat

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  1. Rujuta Prashant Mistry
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Correspondence to Rujuta Prashant Mistry.

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Mistry, R.P., Shah, C. & Jat, R. A New Reverse-Phase High Performance Liquid Chromatography Method for Simultaneous Estimation of Fimasartan, Rosuvastatin Calcium, and Amlodipine Besylate in Combination. Pharm Chem J 56, 416–420 (2022). https://doi.org/10.1007/s11094-022-02644-9

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  • DOI: https://doi.org/10.1007/s11094-022-02644-9

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