Sun, 17 Dec 2017

RP- HPLC Method Development and Validation for Simultaneous Estimation of Ambroxol Hydrochloride and Cefpodoxime Proxetile in Pharmaceutical Dosage form

 

Jigar Goswami1*, Jagdish Kakadiya2, Nehal Shah1

 

1. Quality Assurance Department, Indubhai Patel College of Pharmacy and Research Centre, Dharmaj, Petlad-Khambhat road, Anand, Gujarat, India.

2. Pharmacology Department, Indubhai Patel College of Pharmacy and Research Centre, Dharmaj, Petlad-Khambhat road, Dharmaj, Anand, Gujarat, India.


 

ABSTRACT

A Reversed-Phase High Performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous determination of Ambroxol Hydrochloride and Cefpodoxime Proxetile in combined tablet dosage form. The analysis was carried out using Phenomenex Luna C – 18, pre-packed column. Mobile phase, containing Acetonitrile: 0.05 M Potassium Dihydrogen Ortho Phosphate Buffer (70:30) pH adjusted to 6.7 with Tri ethyl Amine was pumped at a flow rate of 1.0 mL/min with UV-detection at 245 nm. Retention time was 3.34 ± 0.01 min and 4.77 ± 0.01 min for Ambroxol Hydrochloride and Cefpodoxime Proxetile, respectively. The method was validated for linearity, accuracy, precision, and specificity. The method showed good linearity in the range of 30 - 60 μg/ml for Ambroxol Hydrochloride and 50 - 100 μg/ml for Cefpodoxime Proxetile. The detection limit of the proposed method was 4.56 and 12.51 μg/ml and the quantification limit was 13.82 and 37.92 μg/ml for Ambroxol Hydrochloride and Cefpodoxime Proxetile, respectively. The % recovery was within the range between 99.57% and 100.27% for Ambroxol Hydrochloride and % recovery was within the range between 99.89% and 100.86% for Cefpodoxime Proxetile. The % R.S.D for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Ambroxol Hydrochloride and Cefpodoxime Proxetile in combined tablet dosage form.

Keywords Ambroxol Hydrochloride, Cefpodoxime Proxetile, High Performance Liquid Chromatography Method, Validation 


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