Abstract

NOVEL RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF PRAZOSIN AND NSAIDS IN BULK, PHARMACEUTICAL FORMULATIONS AND HUMAN SERUM

Shabana Naz Shah, Najma Sultana, Najmul Hasan* , Mohammed Saeed Arayne

Abstract

Here in this article we are describing about a simple, isocratic reverse phase high-performance liquid chromatographic (RP-HPLC) method developed and validated for the simultaneous determination of Prazosin (PRZ) and non-steroidal anti-inflammatory drugs (NSAIDs) (diclofenac sodium, flurbiprofen, mefenamic acid, meloxicam and naproxen). This method was successfully applied for quantification of respective drugs in bulk, dosage formulations and human serum. Chromatographic separation was achieved at 240nm on the Nucleosil® C18 (250mm x 4.6mm, 10μm), ambient temperature using mobile phase consisting of methanol: acetonitrile (85:15 v/v pH 3.0 adjusted by phosphoric acid 85 %). Flow rate was 1.0 mL min-1 with an average operating pressure of 140 kg/cm2. Calibration curves were linear over range of 2.5-1000 μg mL-1 with a correlation coefficient 0.9997±0.0002. The limit of detection (LOD) and limit of quantification (LOQ) were in the ranges of 4.0-45.1 ng mL-1 and 12.1-136.6 ng mL-1, respectively. Suitability of this method for the quantitative determination of the drugs was proved by validation in accordance with the requirements laid down by International Conference on Harmonization (ICH) guidelines. Method was validated in accordance with ICH and AOAC guidelines and is applicable to the routine analysis of PRZ and NSAIDs, alone or in combination.

Keywords: Prazosin; NSAIDs; Method Validation; Isocratic; RP-HPLC; Human Serum.