World Journal of
Pharmaceutical and Life Sciences

REASEARCH ARTICLE ON RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF TRABECTEDIN FOR THE ESTIMATION OF API AND PHARMACEUTICAL FORMULATION

Miss. Shital Subhash Khandagale*, Miss. Pawar Madhuri, Mr. Nilesh Sopana Kothare, Dr. Waghmare Santosh

ABSTRACT

A reliable and efficient Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Trabectedin in active pharmaceutical ingredients (API) and pharmaceutical formulations. The method employed a [specify column type, e.g., C18] column with a mobile phase comprising [specify solvents, e.g., acetonitrile and buffer] in an optimized ratio. The detection wavelength was set at [specify wavelength], ensuring high sensitivity. Validation was performed in accordance with ICH guidelines, covering key parameters such as linearity, accuracy, precision, robustness, and specificity. The method demonstrated excellent linearity across the tested concentration range with a correlation coefficient (R²) > [value]. Accuracy was confirmed through recovery studies, and precision was validated with low variability in intra-day and inter-day analyses. This validated method is robust and suitable for routine quality control and analysis of Trabectedin in APIs and pharmaceutical products.

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