Forced degradation of valsartan: Development and validation of stability indicating RP-HPLC method

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Çıkla Yılmaz D., Bebek B., Karaderi S.

The Pharma Innovation Journal, cilt.8, sa.3, ss.510-516, 2019 (Hakemli Dergi)

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 8 Sayı: 3
  • Basım Tarihi: 2019
  • Dergi Adı: The Pharma Innovation Journal
  • Derginin Tarandığı İndeksler: Other Indexes
  • Sayfa Sayıları: ss.510-516
  • Marmara Üniversitesi Adresli: Evet

Özet

In the present work, a new validated stability indicating HPLC method for quantitative determination of valsartan in tablet formulation was developed. The column was Inertsil ODS-3 (4.0 x 125 mm id; 5µm particle size) and the mobile phase was composed of 50 mM NaH2PO4 (pH 2,6) - methanol (35:65, v/v) with a flow rate 1 ml/min. Eluents were monitored by DAD detector at 254 nm. Calibration curve was linear in the concentration range 2,4 – 60 µg/ml (R2>0.999). Valsartan was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. The developed method was found to give good separation between pure drug and degraded product. The proposed method was successfully applied for the stability assay of valsartan in tablet formulation and validated as per ICH guidelines.