ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ERLOTINIB HYDROCHLORIDE BULK AND IN PHARMACEUTICAL DOSAGE FORM

  • V S Saravanan Dept of Pharmaceutical Analysis, The Erode College of pharmacy, Perundurai Main Road, Vallipurathanpalayam (po), Veppampalayam, ERODE – 638112, Tamilnadu, INDIA.
  • Bojja Mallikarjuna Rao Dept of Pharmaceutical Analysis, The Erode College of pharmacy, Perundurai Main Road, Vallipurathanpalayam (po), Veppampalayam, ERODE – 638112, Tamilnadu, INDIA.

Abstract

A simple, precise, and accurate RP – HPLC method was developed and validated for the  determination of Erlotinib Hydrochloride in bulk and tablet dosage form. Gradient elution at a flow rate of 1.0 mL/min was employed on zorbax XDB C18 (150 X 4.6 I.D., 5µm particle size) at ambient temperature. The mobile phase consisted of Acetonitrile and 0.02M ammonium acetate, adjusted to pH 3.3 with acetic acid. Acetonitrile and water(50:50) was used as a diluents. The UV detection wavelength was 247nm and 20µL of sample was injected. The retention times of Erlotinib Hydrochloride was found to be 4.576 min. The linearity was obtained in the range of 50 – 150 µg/mL. The % RSD for precision and accuracy of the method was found to be less than 1%.  The method was validated as per the ICH guideline. The proposed method was suitable for the analysis of Erlotinib Hydrochloride in tablet formulation for quality control purpose.

Key Words: Erlotinib Hydrochloride, RP – HPLC, UV, %RSD, Method validation

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Author Biography

V S Saravanan, Dept of Pharmaceutical Analysis, The Erode College of pharmacy, Perundurai Main Road, Vallipurathanpalayam (po), Veppampalayam, ERODE – 638112, Tamilnadu, INDIA.

Head, Dept of Pharmaceutical Analysis, The Erode College of pharmacy, ERODE – 638112,Tamilnadu, INDIA

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How to Cite
Saravanan, V., & Rao, B. (2013). ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ERLOTINIB HYDROCHLORIDE BULK AND IN PHARMACEUTICAL DOSAGE FORM. Journal of Drug Delivery and Therapeutics, 3(1). https://doi.org/10.22270/jddt.v3i1.344