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Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF MICAFUNGIN IN BULK AND INJECTABLES FORMULATION

Vivek Jain1, Priyanka Sharma*1, Navjot Singh1, Prabhat Kumar Jain2

1NRI Institute of Pharmacy, Bhopal, Madhya Pradesh, India

2Scan Research Laboratories, Bhopal, Madhya Pradesh, India

ABSTRACT

Micafungin is an antifungal drug. It belongs to the antifungal class of compounds known as echinocandins and exerts its effect by inhibiting the synthesis of 1, 3-beta-D-glucan, an integral component of the fungal cell wall. A reversed-phase high performance liquid chromatography (RPHPLC) method was developed and validated for the estimation of micafungin in bulk and injectable formulation. The separation was achieved on Thermo C18 analytical column (250 mm × 4.6 mm i.d., 5.0 μm) using 20mM KH2PO4: acetonitrile (pH 3.0 with orthophosphoric acid) in the ratio 20:80 v/v as mobile phase and at a flow rate of 1.0 ml/min. Detection was carried out using a UV detector at 264 nm. The total chromatographic analysis time per sample was about 7.0min with micafungin eluting at retention time of about 4.569±0.3min. The method was validated for accuracy, precision, specificity, linearity and sensitivity. Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The standard curve was linear over the concentration range of 525μg/ml with r2 close to one (0.999). The limit of detection (LOD) and limit of quantitation (LOQ) obtained for micafungin were 0.32μg/ml and 1.05μg/ml respectively. The developed and validated method was successfully applied for the quantitative analysis of mycamine 50mg injection. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the determination of micafungin in injectable formulation.

Keywords: Analytical method development, Reversed phase HPLC method, ICH guidelines, Tablet dosage forms, Accuracy and precision


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