Volume : 12, Issue : 06, June – 2025
Title:
METHOD DEVELOPMENT AND VALIDATION OF DRUG IN IT’S BULK AND PHARMACEUTICAL DOSAGE FORM BY RP HPLC
Authors :
Komal Sham Khot*, Vishakha Bhaskar Ingole, Prof. Sushma Rathod, Dr. L. R. Gandhi, Dr. Nitin S. Bhajipale
Abstract :
High-Performance Liquid Chromatography (HPLC) is widely recognized for its precision, sensitivity, and reliability in pharmaceutical analysis, particularly in the estimation of drugs from complex dosage forms. The present study was aimed at developing and validating a stability-indicating Reverse Phase HPLC (RP-HPLC) method for the quantitative estimation of Adefovir Dipivoxil (ADF) in its bulk and tablet dosage form. Chromatographic separation was achieved using an Inertsil C18 column (4.6 × 250 mm, 5 µm), with a mobile phase consisting of Methanol: Phosphate Buffer (70:30) at pH 3.5 and a detection wavelength of 262 nm. The method yielded a sharp and well-resolved peak for ADF with a retention time of 4.21 minutes, asymmetry of 1.14, and theoretical plates above 230,000.
The method was validated according to ICH Q2(R1) guidelines and demonstrated excellent linearity in the concentration range of 80–120% of the test concentration (R² ≈ 0.999), along with acceptable levels of accuracy, precision, specificity, robustness, and ruggedness. Forced degradation studies under various stress conditions—acidic, alkaline, oxidative, thermal, and photolytic—confirmed the method’s stability-indicating nature, as all degradation products were well resolved from the main peak. The developed method was successfully applied to the analysis of a marketed formulation (Adesera), with mean assay and recovery values close to 100%, confirming its suitability for routine quality control of Adefovir Dipivoxil.
Keywords: Adefovir Dipivoxil; RP-HPLC; Method Validation; Stability-Indicating Method; Forced Degradation; Tablet Dosage Form; ICH Guidelines.
Cite This Article:
Please cite this article in press Komal Sham Khot et al., Formulation And Evaluation Of Dexamethasone Sugar Coated Tablet, Indo Am. J. P. Sci, 2025; 12(07).
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