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Development of Validated Stability-Indicating RP-HPLC Method Based on Forced Degradation Studies for the Quantitative Analysis of Olaparib in Tablet Dosage
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| Author:
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, ANJU SINGHAL, DR. VINEET JAIN, DR. ZARNA DEDANIA
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| Abstract:
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A simple, accurate, precise, and stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative determination of olaparib in tablet dosage forms. Chromatographic separation was achieved using a suitable C18 column with a mobile phase comprising a mixture of aqueous buffer and organic solvent under optimized conditions. The analyte was detected using UV detection at an appropriate wavelength, providing sharp peak symmetry and satisfactory resolution.
The developed method was subjected to forced degradation studies under various stress conditions, including acidic, alkaline, oxidative, thermal, photolytic, and hydrolytic degradation, to evaluate its stability-indicating capability. Olaparib exhibited varying degrees of degradation under the applied stress conditions, while the degradation products were well resolved from the drug peak, demonstrating the specificity of the method.
The method was validated according to International Council for Harmonisation (ICH) guidelines with respect to system suitability, specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ). The calibration curve showed excellent linearity over the selected concentration range with a high correlation coefficient. Recovery studies confirmed the accuracy of the method, while precision studies demonstrated acceptable repeatability and intermediate precision. The method also proved to be robust against small deliberate variations in chromatographic conditions.
The validated RP-HPLC method was successfully applied for the routine quantitative analysis of olaparib in tablet dosage forms and can be effectively used for quality control, stability testing, and pharmaceutical analysis.
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| Keyword:
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Olaparib; RP-HPLC; Stability-Indicating Method; Forced Degradation Studies; Method Validation;ICH Guidelines; Tablet Dosage Form
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2026.18.02.001
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| Download:
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