Assessments of Valsartan in the presence of Nebivolol or Amlodipine in solid formulations and its discriminative dissolution behavior via RP‑HPLC and RP‑UPLC methods.
Annadi, A., Shoheib, R., Mohamed, A. (2020). Assessments of Valsartan in the presence of Nebivolol or Amlodipine in solid formulations and its discriminative dissolution behavior via RP‑HPLC and RP‑UPLC methods.. EKB Journal Management System, 63(8), 2837-2851. doi: 10.21608/ejchem.2020.18176.2116
Abdelaziz Annadi; Ragaa Elsheek Shoheib; Ashraf Mohamed. "Assessments of Valsartan in the presence of Nebivolol or Amlodipine in solid formulations and its discriminative dissolution behavior via RP‑HPLC and RP‑UPLC methods.". EKB Journal Management System, 63, 8, 2020, 2837-2851. doi: 10.21608/ejchem.2020.18176.2116
Annadi, A., Shoheib, R., Mohamed, A. (2020). 'Assessments of Valsartan in the presence of Nebivolol or Amlodipine in solid formulations and its discriminative dissolution behavior via RP‑HPLC and RP‑UPLC methods.', EKB Journal Management System, 63(8), pp. 2837-2851. doi: 10.21608/ejchem.2020.18176.2116
Annadi, A., Shoheib, R., Mohamed, A. Assessments of Valsartan in the presence of Nebivolol or Amlodipine in solid formulations and its discriminative dissolution behavior via RP‑HPLC and RP‑UPLC methods.. EKB Journal Management System, 2020; 63(8): 2837-2851. doi: 10.21608/ejchem.2020.18176.2116

Assessments of Valsartan in the presence of Nebivolol or Amlodipine in solid formulations and its discriminative dissolution behavior via RP‑HPLC and RP‑UPLC methods.

Egyptian Journal of Chemistry
Article 4, Volume 63, Issue 8, August 2020, Page 2837-2851  XML PDF (1.26 MB)
Document Type: Original Article
DOI: 10.21608/ejchem.2020.18176.2116
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Authors
Abdelaziz Annadi email 1; Ragaa Elsheek Shoheib1; Ashraf Mohamed2
1Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt.
2Chemistry Department, Faculty of Science, Ain Shams University, Abbassia, Cairo, 11566, Egypt.
Abstract
The current work provides method development and validation of a rapid, robust, precise and accurate RP-HPLC and RP-UPLC for the assessment of Valsartan (VAL) in the presence of Nebivolol (NEB) or Amlodipine (AML) in their combined solid dosage form, following the ICH instructions. In RP-HPLC, Separation was achieved on an Inertsil column, (C18, 150 mm x 4.6 mm, 5μm) with (30:20:50 v/v%), mobile phase of (buffer pH 3.0: acetonitrile: methanol) in an isocratic mode with a flow rate 1.0 mL/min and using photodiode array (PDA) detection at 281 nm. However, in RP-UPLC, Mobile phase was phosphate buffer pH 3.0 and acetonitrile in a ratio of 55:45 v/v% at a flow rate 0.3 mL/min on an Eclipse Plus column, (C18, 1.8 µm, 50 mm × 2.1 mm), while detection at 240 nm on a PDA detector. Calibration curves were linear over the concentration ranges of (0.80-72.00,0.05-4.50) and (4.00-144.00, 0.125-4.50)µg/mL, for the assay and in-vitro drug release profile of (VAL, NEB) and (VAL, AML), respectively. In-Vitro dissolution studies revealed that not less than (NLT) 85% of the labeled amount of VAL and AML was released within 15 min and NLT 85% of the labeled amount of NEB was dissolved within 20 min from their fixed combination solid dosage forms.
Keywords
Amlodipine, Nebivolol and Valsartan; Development, validation and dissolution; RP-HPLC and RP-UPLC
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