ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ERLOTINIB HYDROCHLORIDE BULK AND IN PHARMACEUTICAL DOSAGE FORM
A simple, precise, and accurate RP â€“ HPLC method was developed and validated for theÂ 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., 5Âµm 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 20ÂµL 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 â€“ 150 Âµg/mL. The % RSD for precision and accuracy of the method was found to be less than 1%. Â 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 â€“ HPLC, UV, %RSD, Method validation
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