European Journal of Biomedical and Pharmaceutical Sciences

BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SERTRALINE HCL IN RAT PLASMA BY HPLC

Pallavi D. Gaikwad* and Sonali Mahaparale

ABSTRACT

Objective: An accurate, simple, reproducible and sensitive bioanalytical method for the determination of sertraline HCL in pharmaceutical dosage form was developed and validated using a reversed-phase C18 column (250 mm X 4.6 mm i. d, 5 μm particle size) with isocratic elution. Methods: A mixture of Methanol: Water (90:10 v/v), was used as a mobile phase at the flow rate of 1.5 ml/min and detector wavelength at 273 nm. The retention time of Sertraline was found to be 6.3 minutes (min). The method was statistically validated for the linearity, accuracy, precision and robustness. Results: The linearity of Sertraline Hydrochloride was in the range of 20 to 400μg/ml. This method showed an excellent linear response with the correlation coefficient (R2) value of 0.994 for the Sertraline HCl. The recovery of the drug was ranged from 99.75 to 99.81 %. An intra-day and inter- day precision study of the new method was less than the maximum allowable limit (% RSD<2.0). Conclusion: The proposed method was cost effective, which can be used for the estimation of Setraline in bulk and in solid dosage forms.

Keywords: Sertraline, HPLC, Isocratic, Retention time, Validation.