Login

Journal Front Page

News & Events

  • Call for article for January 2025 issue
    • Submissions of Review, Research Article, Short Communication and Case study are being accepted for the current and future issues before 15 December, 2024 of this journal by online process or editor@ajper.com, or ajper.editor@gmail.com. Further information can be found at www.ajper.com.
  • October 2024 Issue published
    • Dear Researcher, It Pleased to inform you that, Asian Journal of Pharmaceutical Education and Research, has successfully launch Volume 13, Issue 4 (October 2024 Issue). You can find the article on http://ajper.com/current_issue.php Article also invited for the Next coming Issue from your side. For More details Visit: www.ajper.com
  • Application For Reviewer
    • We are now going to reconstitute our editorial board members of Reviewer. Please send your resume at ajper.editor@gmail.com and be a part of the editorial board member as Reviewer.
  • AJPER Impact facor
    • It is to pleasure that Ajper SJIF imact facor has increse from 5.019 to 7.014. Also global impact factor incresed from 0.654 to 0.765.
  • ICV
    • AJPER Rank with Index Copernicus Value 61.10 due to high reputation at International Level

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


[Full Text Article]