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Development and Validation of RP-UHPLC Method for Determination of Sertraline in Bulk Drug and Dosage Form

S. P. Pawar, S. Patil, V. Chaudhari

Objective: The new, rapid, sensitive, simple, precise and accurate Reversed- Phase Ultra High Performance Liquid Chromatography (RP-UHPLC) method was developed and validated for determination of Sertraline in bulk drug and Pharmaceutical dosage form.

Methods: The UV Spectrum of Sertraline in diluent showed maximum wavelength at 273nm. In RP-UHPLC method separation achieved by Agilent C18 (75mm×3.9mm, 2μm particle size) column using Acetonitrile :( 0.1%OPA) Water (80:20v/v) as mobile phase at flow rate 0.7ml/min. Injection volume is 20μl. RP-UHPLC detection carried out at 273nm.

Results: In RP-UHPLC method retention time was found to be 3.75min. The Calibration curve was found to be linear (r2=0.999) with concentration range of 10-50μg/ml. The Accuracy (% recovery) for Sertraline was found to be 99-100%. The % RSD (intra-day and inter precision) values are not more than 2% hence the developed methods are accurate and precise. The LOD and LOQ were found to be 0.2085μg/ml and 0.6321μg/ml respectively.

Conclusion: The developed method was validated with respect to linearity, accuracy, precision, robustness, ruggedness, LOD and LOQ as per ICH guidelines. The proposed method was used for routine analysis of Sertraline in Bulk drug and Solid dosage Form.