Development and Validation of RP-HPLC Method for Simultaneous Estimation of Cefpodoxime Proxetil and Ambroxol Hydrochloride in Bulk and in Tablets

Abstract

A new simple, precise, accurate and selective RP-HPLC method has been developed and validated for simultaneous estimation of cefpodoxime proxetil and ambroxol hydrochloride in tablet dosage form. The method was carried out on a Qualisil RP C-8 (250 mm x 4.6 mm, 5 μm) column with a mobile phase consisting of acetonitrile: 0.025 M potassium dihydrogen phosphate buffer (70:30 v/v) pH adjusted to 4.0 with ortho-phosphoric acid and flow rate of 1.0 mL/min. Detection was carried out at 248 nm. Diclofenac sodium was used as an internal standard. The retention time for cefpodoxime proxetil, ambroxol hydrochloride and diclofenac sodium was found to be 3.89, 2.69 and 5.52 min, respectively. The cefpodoxime proxetil and ambroxol hydrochloride followed linearity in the concentration range of 3- 18 µg/mL (r²= 0.9981) and 2- 12 µg/mL (r²= 0.9980), respectively. The amount of both these drugs estimated by proposed method was found to be in good agreement with label claim. The developed method was validated for sensitivity, accuracy, precision, ruggedness and robustness. The LOD and LOQ were found to be 0.18 and 0.55 µg for cefpodoxime proxetil and 0.09 and 0.30 µg for ambroxol hydrochloride. The proposed method can be used for routine analysis of both these drugs simultaneously in their combined dosage form.