RP-HPLC method development and validation for Quantification of Mebendazole in API and Pharmaceutical Formulations
PharmaTutor (May- 2016)
Print-ISSN: 2394 - 6679
e-ISSN: 2347 - 7881
(Volume 4, Issue 5)
Received On: 21/12/2015; Accepted On: 04/01/2016; Published On: 01/05/2016
Durgesh Rameshlal Parakh1*, JK Madagul1, HR Mene2, MP Patil1, SJ Kshirsagar1
1Department of Pharmaceutics,
MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik, Maharashtra, India.
2Department of Pharmaceutics, Government College of Pharmacy,
Opp. Government Polytechnic, Osmanpura, Aurangabad, Maharashtra, India.
ABSTRACT: A new simple and sensitive RP-HPLC method was developed and validated for quantification of Mebendazole in Active Pharmaceutical Ingredient (API) and pharmaceutical formulation. The gradient RP-HPLC method was developed on Agilent (India) C18 250 × 4.6 mm, 5 μ column using mobile phase as acetonitrile: water pH 3.0 with orthophosphoric acid (90:10 v/v) at a flow rate of 1 mL/min and detection was carried out at 234 nm using UV-Visible detector (UV 3000 M). The method was validated linearity, limit of detection, limit of quantification, precision, ruggedness, robustness, accuracy and specificity were found to be satisfactory. The method was found to be linear in the concentration range of 20-100 μ/mL with correlation coefficient of 0.999. The method was validated according to the ICH guidelines and was proved to be specific, linear, accurate, precise and economical for the analysis of Mebendazole.
How to cite this article: Parakh DR, Madagul JK, Mene HR, Patil MP, Kshirsagar SJ; RP-HPLC method development and validation for Quantification of Mebendazole in API and Pharmaceutical Formulations; PharmaTutor; 2016; 4(5); 46-51