Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AMBROXOL, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL IN BULK AND LIQUID DOSAGE FORM BY R P-HPLC METHOD

*Hina Bagada, Hitesh Panchal, Priya Patel , Aashka Jani

ABSTRACT

A simple Reverse phase liquid chromatography method has been developed and subsequently validated for the determination of Ambroxol, Chlorpheniramine Maleate and Phenylephrine HCl in liquid dosage form. The saparation was carried out using mobile phase consisting methanol : acetonitrile (50%:50%) and phosphate buffer 5 pH containing 0.75% TEA set by formic acid(40%:60%v/v) gave resolution of peaks and satisfied retention time in HPLC.The good saparation carried out using C-18 (250mm × 4.6mm i.d with particle size of 5 μm )used with flow rate 0.95 ml/min using UV detection at 261nm.the described method was linear over the concentration range of 32-48 μg/ml (R2 = 0.998 )for Ambroxol, 6.4-12.8 μg/ml (R2 = 0.997) for Chlorpheniramine maleate and 11.2- 22.4 μg/ml (R2 = 0.990) for Phenylephrine HCl. The saparation was achieved with in 15 min. The mean Recovery studies was found to be 99.9-99.95% for AMB and 100.0-100.77% for CPM and 100.0-100.72% for PH. Whereas the LOD and LOQ value was found to be 11.58μg/ml and 35.092 μg/ml for AMB & 0.66 μg/ml and 2.02 μg/ml for CPM And 7.04 μg/ml and 21.36 μg/ml for PH. The result of the study showed that the proposed RP-HPLC method is simple, rapid, precise, accurate and cost effective which is useful for the routine determination of the Ambroxol, Chlorpheniramine Maleate and Phenylephrine HCl in Bulk and Liquid Dosage Form.

Keywords: RP-HPLC, Ambroxol, Chlorpheniramine Maleate, and Phenylephrine HCl, Validation.