International Journal of Pharmaceutics & Drug Research

Kavita Jain*, Mrs. Ketkee Mandawar, Dr. Pratyush Jain

ABSTRACT

This study aimed to develop and validate a stability-indicating method for the estimation of pantoprazole and ondansetron in a marketed formulation. The method development involved optimizing the experimental conditions, including the choice of mobile phase, column, and detection wavelength. Forced degradation studies were conducted to identify and characterize potential degradation products. The developed method was validated according to regulatory guidelines, including specificity, linearity, accuracy, precision, robustness, and system suitability. The method demonstrated excellent specificity by effectively separating the analytes from degradation products and excipients commonly found in the formulation. It exhibited good linearity over a suitable concentration range and showed accurate and precise results. The method was robust, with consistent performance under different experimental conditions. The validated stabilityindicating method was successfully applied to the analysis of a marketed formulation containing pantoprazole and ondansetron. The method provided accurate and reliable results for the determination of drug content in the formulation, ensuring quality control and stability testing. The developed and validated method offers a reliable tool for routine analysis in pharmaceutical quality control laboratories, enabling accurate quantification of pantoprazole and ondansetron in the marketed formulation. It contributes to ensuring the safety, efficacy, and stability of the formulation throughout its shelf life.

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