Development and Validation of New Analytical ...

Development and Validation of New Analytical Method for the Determination of Dosulepin Hydrochloride in Bulk and Pharmaceutical Dosage Form using Rp-Hplc

Author Name : Kamthal Ayesha, Dr. P. Salomi

DOI: https://doi.org/10.56025/IJARESM.2023.1201241724

ABSTRACT A simple, selective, and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method has been proposed for the estimation of Dosulepin Hydrochloride in pure form as well as in its pharmaceutical formulation. The chromatography was carried out on C18 (Phenomenex Luna 150 x 4.6 mm x 5μm) using a mobile phase of acetonitrile: Disodium hydrogen phosphate (pH 3.0 with 0.1% OPA) (70:30 V/V). The flow rate was 1.0 ml/min with detection at 212 nm. The retention time was found to be 3.015 min. The proposed method was validated for selectivity, precision, linearity and accuracy. The linearity was found in the range of 10-60 μg/mL respectively. All validation parameters were within the acceptable range. From the recovery studies, non-interference of excipients with the drug was identified and % recovery was found within 100 – 102%. The developed method was successfully applied to estimate the amount of drug in tablet dosage form.