RP-HPLC Method Development and Validation For Simultaneous Estimation of Paracetamol and Alprazolam in Bulk and Pharmaceutical Dosage Forms

Abstract

A new Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for estimation of Paracetamol and Alprazolam in bulk and tablet dosage forms using UV-detector.A RP Cell Pack C18 column (250 mm × 4.6 mm, 5 µ particle size) using acetonitrile and water (80:20 % V/V) as mobile phase by maintaining flow rate of 1 mL/min at 236 nm as detection wavelength.The peaks were eluted at 4.8 and 6.2 mins for Paracetamol and Alprazolam, respectively.The method was validated in accordance with ICH guidelines, the linearity curve for Paracetamol was obtained over the range of 50-175 µg/mL, and it was found to be linear with y = 1961x + 9226 (r 2 = 0.999).The linearity curve for Alprazolam was obtained over the range of 0.25-1.5 µg/mL and was found to be linear with y =23328x + 939.3 (r 2 = 0.998).The percentage recoveries were found to be 99-101% and 99-102%, respectively.The system suitability parameters such as number of theoretical plates and tailing factor were found to be 7242, 1.56 for PAR and 6755, 1.15 for ALP.Hence the developed RP-HPLC method was found to be simple, accurate, economical, rapid and can be applied for routine analysis of these drugs in their combined formulations.