Simultaneous Determination and Validation of Miconazole Nitrate with the Anitmicrobial Preservatives using RP-HPLC Method: for Benzoic Acid, Sodium Propyl Hydroxyl Benzoate, and Sodium Methyl Hydroxy Benzoate in Pharmaceutical Cream

Author(s)

Asghar, S., Sheikh, S., Ahmad, S.

Author's Affiliation

Abstract

A new HPLC-RP method has been developed and validated for the simultaneous determination of Benzoic acid, sodium methyl hydroxyl benzoate, sodium propyl hydroxyl benzoate and miconazole nitrate in combined dosage form. The method uses a Qualisil, C18 column, 250 mm x 4.6 mm, 5µm in isocratic elution. The mobile phase consisted of a mixture of 0.6% Ammonium acetate: ACN: Methanol (380: 300: 320); which pumped at a flow rate of 2.0ml/min. Tetrahydrofuran: methanol in 1:1 ratio was used as diluent. The detector was set at 235nm. The retention time of the Benzoic acid, sodium methyl hydroxyl benzoate, sodium propyl hydroxyl benzoate and miconazole nitrate was found to 1.280, 1.698, 2.275 and 3.500 respectively. The validation study was carried out fulfilling the ICH guidelines in order to prove that the new analytical method, meets the reliability characteristics, and these characteristics showed the capacity of analytical method to keep, throughout the time, the fundamental criteria for validation: selectivity, linearity, precision, accuracy and sensitivity. The method was applied during the quality control of miconazole cream in order to quantify the drug (miconazole nitrate) and preservatives; and proved to be suitable for rapid and reliable quality control method. The detector response was linear in the range of 25 to 150 μg/ml, 20.0-160.0μg/ml, 4-14 μg/ml and 150-1500 μg/ml, for Benzoic acid, sodium methyl hydroxyl benzoate, sodium propyl hydroxyl benzoate and miconazole nitrate respectively.

Keywords

RP-HPLC, Benzoic acid, Sodium Propyl Hydroxyl Benzoate, Sodium Methyl Hydroxyl Benzoate and Miconazole Nitrate, Validation, Antibacterial Formulation and Method Development

Cite This Article

Asghar, S., Sheikh, S., & Ahmad, S. (2014). Simultaneous Determination and Validation of Miconazole Nitrate with the Anitmicrobial Preservatives using RP-HPLC Method: for Benzoic Acid, Sodium Propyl Hydroxyl Benzoate, and Sodium Methyl Hydroxy Benzoate in Pharmaceutical Cream. International Journal for Pharmaceutical Research Scholars, 3(1), 106-113.