European Journal of Biomedical and Pharmaceutical Sciences

RP-HPLC METHOD DEVELOPMENT AND VALIDTION FOR SIMULTANEOUS ESTIMATION OF PHENYLEPHRINE, AMBROXOL AND DESLORATIDINE

Putta Sridevi Bhagyasri, Penumantra Venkata Kishore*, Yandamuri Narayudu, Dr. Devanaboyina Narendra, Gadi Vijayalakshmi

ABSTRACT

A simple, accurate, precise method was developed for the simultaneous estimation of the Phenylephrine (PHE), Ambroxol (AMB), and Desloratidine (DES) in solid dosage form. Separation of PHE, AMB, and DES were carried on Kromosil C18 (150x4.6mm, 5.) column using 0.01N KH2PO4 buffer (pH-3.35): Acetonitrile (45:55 v/v) used as Mobile phase and pumped through column at a flow rate of 0.8 ml/min. UV detection was done at 220. Temperature was maintained at 30°C. Retention time of PHE, AMB and DES were found to be 2.226 min, 2.747 min and 3.810 min respectively. Linearity range of PHE, AMB and DES were 1.25-7.5 μg/ml for PHE, 15-90 μg/ml for AMB and 1.25 & 7.5 μg/ml for DES. The regression equation for PHE was found to be y = 60204.14x + 977.06 (slope, intercept and correlation coefficient were found to be 60204.14, 977.06 and 0.999 respectively) and linear over beer’s range of 1.25-7.5 g/ml. The regression equation for AMB was found to be y = 60089.2x + 6507.6 (slope, intercept and correlation coefficient were found to be 60089.2, 6507.6 and 0.999 respectively) and linear over beer’s range of 15-90 g/ml. The regression equation for DES was found to be y = 61836.91x + 2118.33 (slope, intercept and correlation coefficient were found to be 61836.91, 2118.33 and 0.999 respectively) The values of % RSD are less than 2% indicating accuracy and precision of the method. LOD and LOQ are found to be within the limit. This method was validated following the ICH guidelines. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.

Keywords: Phenylephrine, Ambroxol, Desloratidine, RP-HPLC.