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Vol. 7, Issue 4 (2018)

Stability indicating RP-HPLC method development and validation for simultaneous estimation of aspirin and isosorbide mononitrate in pharmaceutical dosage form

Author(s):
Nidhi S Patel, Dr. Dulendra P Damahe, Dr. Shailesh V Luhar and Dr. Sachin B Narkhede
Abstract:
A simple, rapid, precise, economic, and accurate Stability-Indicating RP-HPLC method were developed and validated for the estimation of Aspirin and Isosorbide Mononitrate in pharmaceutical dosage form. Method include Shiseido C18 (250 mm × 4.6 mm, 5μm) column and Phosphate buffer (pH: 4): Methanol (30:75 v/v) as mobile phase at 1.0ml/min flow rate. The detection was carried out at 215nm. Rt was found to be 3.767 min for Aspirin and 2.540 min for Isosorbide Mononitrate. For stability study drugs were subjected to acid hydrolysis, alkaline hydrolysis, oxidative degradation and thermal degradation. Pharmaceutical dosage form was more stable than Active pharmaceutical ingredient. The linearity range was found in range of 15-52.5 μg/mL for Aspirin and 6-21μg/mL Isosorbide Mononitrate. Limit of Detection for Aspirin and Isosorbide Mononitrate was found to be 1.01μg/mL and 0.77μg/mL respectively. Limit of Quantitation for Aspirin and Isosorbide Mononitrate was found to be 3.07μg/mL and 2.34μg/mL respectively.
Pages: 217-234  |  1789 Views  404 Downloads


The Pharma Innovation Journal
How to cite this article:
Nidhi S Patel, Dr. Dulendra P Damahe, Dr. Shailesh V Luhar, Dr. Sachin B Narkhede. Stability indicating RP-HPLC method development and validation for simultaneous estimation of aspirin and isosorbide mononitrate in pharmaceutical dosage form. Pharma Innovation 2018;7(4):217-234.
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