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, Abdelaziz; Shoheib, Ragaa Elsheek; Mohamed, Ashraf

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.

Document Type : Original Article

Authors

¹ Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt.

² Chemistry Department, Faculty of Science, Ain Shams University, Abbassia, Cairo, 11566, Egypt.

10.21608/ejchem.2020.18176.2116

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.

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