Method development and validation of simultaneous determination of Sertraline Hydrochlorde and Alprazolam in pharmaceutical dosage form by RP-HPLC

The present work describes a new, simple, precise, and accurate RP-HPLC method for simultaneous estimation of Sertraline Hydrochloride and Alprazolam in pharmaceutical dosage form. Chromatographic separation of the drugs was achieved on a Symmetry C18 (4.6 x 250mm, 5mm, Make: Waters) using KH2PO4 buffer: acetonitrile (adjusted to pH 3.6 with ortho phosphoric acid) in the ratio of 40:60 v/v as mobile phase. Flow rate was 1.0 mL/min and the detection wavelength was 225 nm. The two drugs were satisfactorily resolved with retention time values 2.344 min and 3.286 min for Sertraline Hydrochloride and Alprazolam, respectively. Linearity was found to be in the range of 100 -500 μg /mL for Sertraline Hydrochloride and 1 – 5 μg /mL for Alprazolam with significantly high value of correlation coefficient, (R2 = 0.999 for Sertraline Hydrochloride and 0.999 for Alprazolam). The accuracy of the method was assessed by evaluation of precision (intra-day and inter-day precision % RSD was less than 2% for both Sertraline Hydrochloride and Alprazolam), accuracy (99.84 % for Sertraline Hydrochloride and 100.51 % for Alprazolam). The LOD and LOQ were found to be 0.12 μg /mL and 0.42 μg /mL for Sertraline Hydrochloride and 0.015 μg /mL and 0.05 μg /mL for Alprazolam respectively. All the parameters were found to be within limits, which indicate that the above method was accurate, precise and validated as per ICH guidelines. Hence, it was concluded that the developed method is suitable for routine analysis of Sertraline HCL and Alprazolam due to its less analysis time.

Author(s): Sameena Kouser

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