Stability-Indicating UPLC Method Development and ICH Validation for Quantitative Estimation of Sulphacetamide in Injectable Dosage Forms
Keywords:
Sulphacetamide, UPLC, Method Validation, Stability-Indicating, Parenteral Formulations, ICH Q2Abstract
Background: Stability-indicating analytical methods are essential for ensuring drug quality and regulatory compliance. Sulphacetamide, a sulfonamide antibiotic, is used widely in parenteral formulations for bacterial infections. This study focuses on developing and validating a rapid, accurate, and stability-indicating UPLC method for the quantification of Sulphacetamide in parenteral dosage forms.
Methods: The method was validated in accordance with ICH Q2(R1) guidelines using UPLC systems. Key parameters evaluated included accuracy (at 50%, 100%, and 150% levels), system and method precision, linearity (10–200 µg/mL), robustness (flow rate, temperature, wavelength), ruggedness, and sensitivity (LOD and LOQ).
Results: The method demonstrated excellent precision (method %RSD: 0.01%), high accuracy (recoveries: 99.11–99.55%), and strong linearity (R² = 0.9968). Robustness tests showed minimal variation (%RSD: 0.13–0.16%), while ruggedness confirmed consistent results across instruments and days. The method yielded recoveries between 99.11% and 99.55%, with %RSD ≤ 0.25%, R² = 0.9968.
Conclusion: This validated UPLC method is rapid, sensitive, and robust for routine quantification of Sulphacetamide in parenteral formulations. Its reproducibility and stability-indicating capability make it suitable for pharmaceutical quality control and potential pharmacokinetic research
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