Abstract:
The purpose of this work is to develop a sensitive, selective, and validated RP-HPLC
assay of Tianeptine Sodium in bulk drug and tablet form. Tianeptine Sodium was
analyzed on INERTSIL ODS C18 column using isocratic elution with acetonitrile and
water (pH 3) in ratio of 55:45. The mobile phase at a flow rate of 1.0 ml/min,
Injection volume 10 μl and wavelength of detection was kept at 220 nm. The retention
time for Tianeptine Sodium was 3.783 min. The linearity of the proposed method was
investigated in the range of 10-80 μg/ml. Correlation coefficient was 0.9997, the limit
of detection and limit of quantification was 0.3214 μg/ml and 0.9740 μg/ml
respectively. Proposed methods were validated as per ICH guidelines for linearity,
accuracy, precision, specificity and robustness for estimation of Tianeptine Sodium in
commercially available tablet dosage form and results were found to be satisfactory.
Dissolution profiling of Tianeptine Sodium tablets were done and their f1 & f2 were
calculated and were obtained within range which suggested that these tablets were comparable. Thus the developed and validated RP-HPLC method can be used
successfully for marketed formulations
