Validation of developed method by RP-HPLC for estimation of Prasugrelin human plasma and studying the stability of the drugs in plasma

Authors

  • Kumar S. Ashutosh Department of Pharmacy, Tripura University, (A Central University), Suryamaninagar, Tripura West, Agartala, Tripura
  • Debnath Manidipa Inspecting Officer (Drugs), O/o, The Deputy Drugs Controller, Pandit Nehru Complex, Gourkhabasti, Agartala, Tripura
  • Rao J.V.L.N. Seshagiri Pharmaceutical Analysis and Quality Assurance, Srinivasarao College of Pharmacy, Pothinamallayyapalem, Madhurawada, Visakhapatnam
  • Sankar D. Gowri Pharmaceutical Analysis, College of Pharmaceutical Sciences, Andhra University, Visakhapatnam

DOI:

https://doi.org/10.3126/kuset.v13i1.21263

Keywords:

High performance liquid chromatography, Potassium dihydrogen phosphate, Acetonitrile, Prasugrel, Accuracy, Lower limit of quantification, Plasma

Abstract

This paper is concern with a reverse phase high performance liquid chromatography (RP-HPLC) bio-analytical method development and validation for Prasugrel in human plasma using photo diode array detector (PDA detector). The HPLC separation was carried out in an isocratic mode on an X-Terra C18 column (4.6 x 150 mm; 5 μm) with a mobile phase consisting of potassium dihydrogen phosphate [pH 3.0] and acetonitrile in the ratio of 30:70 v/v at a flow rate of 1.0 mL/min. The run time was maintained for 5 mins and the detection was monitored at 210 nm. The percentage recovery was found 99.61-100.06 in human plasma. This reveals that the method is quite accurate. The linearity was found 15-40 μg/mL in human plasma. The inter-day and intra-day precision in plasma was found within the limits. The lower limit of quantification (LLOQ) obtained by the proposed method was 0.05 μg/mL. The percentage relative standard deviation (%RSD) obtained for the drug spiked in plasma for stability studies were less than 2 %.

Kathmandu University Journal of Science, Engineering and Technology

Vol. 13, No. 1, 2017, Page: 65-75

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Published

2018-10-04

How to Cite

Ashutosh, K. S., Manidipa, D., Seshagiri, R. J., & Gowri, S. D. (2018). Validation of developed method by RP-HPLC for estimation of Prasugrelin human plasma and studying the stability of the drugs in plasma. Kathmandu University Journal of Science, Engineering and Technology, 13(1), 65–75. https://doi.org/10.3126/kuset.v13i1.21263

Issue

Vol. 13 No. 1 (2017)

Section

Original Research Articles

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