RP-HPLC method development and validation for Quantification of Mebendazole in API and Pharmaceutical Formulations

Durgesh Rameshlal Parakh; M P Patil; J K Madagul; S J Kshirsagar; H R Mene

Durgesh Rameshlal Parakh MET’s Institute of Pharmacy
M P Patil MET’s Institute of Pharmacy
J K Madagul MET’s Institute of Pharmacy
S J Kshirsagar MET’s Institute of Pharmacy
H R Mene Government College of Pharmacy

Keywords: Mebendazole, Anthelmintic, RP - HPLC, Validation, API, ICH

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.

Author Biographies

Durgesh Rameshlal Parakh, MET’s Institute of Pharmacy

Department of Pharmaceutics,
MET’s Institute of Pharmacy,
Bhujbal Knowledge City,
Adgaon, Nashik, Maharashtra, India

M P Patil, MET’s Institute of Pharmacy

Department of Pharmaceutics,
MET’s Institute of Pharmacy,
Bhujbal Knowledge City, Adgaon, Nashik, Maharashtra, India

J K Madagul, MET’s Institute of Pharmacy

Department of Pharmaceutics,
MET’s Institute of Pharmacy,
Bhujbal Knowledge City, Adgaon, Nashik, Maharashtra, India

S J Kshirsagar, MET’s Institute of Pharmacy

Department of Pharmaceutics,
MET’s Institute of Pharmacy,
Bhujbal Knowledge City, Adgaon, Nashik, Maharashtra, India

H R Mene, Government College of Pharmacy

Department of Pharmaceutics,
Government College of Pharmacy,
Government Polytechnic, Osmanpura,
Aurangabad, Maharashtra, India

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