SERTRALINE HYDROCHLORIDE IN MARKETED FORMULA ESTIMATION USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHODAbstract
A study was performed to develop a simple HPLC method for estimating sertraline Hydrochloride in unit dose. The method was created by evaluating the drug sertraline hydrochloride’s solubility in phosphate buffer, pH 4.0, at 254 nm. The chromatographic separation was accomplished on Prominence I LC 2030 C (Shimadzu Corporation, Japan). A 10 µl sample volume and a C18 column (250 x 4.6 mm (5 µm) were employed. The created and improved procedure produced the desired results. A 0.9998 linearity value was discovered. Buffer (Monobasic Potassium Phosphate of Buffer pH 4.0): Acetonitrile: and Methanol (50:25:25) were combined in a mobile phase designed for the technique at a 2.0 ml/min flow rate. Sertraline Hydrochloride was simultaneously identified at 254 nm with a retention time of 10.4±0.2 min. The percentage of the medicine was calculated using the specification limits after a quantitative assay of the commercial formulation. According to ICH guideline Q2R1, validation was completed successfully. The suggested approach can be used for a BE study to assess its applicability further and estimate sertraline Hydrochloride in pharmaceutical formulations.
Kartik Pandya *, Chintan Aundhia and Snehal Patel
Department of Pharmacy, Sumandeep Vidyapeeth, Vadodara, Gujarat, India.
06 February 2023
22 April 2023
31 May 2023
01 October 2023