To Development and Validation RP-HPLC Method for Tinidazole in Bulk and Pharmaceutical Formulation.

A simple, precise, accurate, and robust Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative estimation of Tinidazole in bulk and pharmaceutical dosage forms. Chromatographic separation was achieved using a mobile phase of Acetonitrile and Water (90:10 v/v), with the detection wavelength set at 270 nm. The method demonstrated excellent linearity in the concentration range of 5–30 µg/ml, with a correlation coefficient (r²) of 0.9996. The Limit of Detection (LOD) and Limit of Quantitation (LOQ) were found to be 2.5070 µg/ml and 7.5912 µg/ml respectively. Validation parameters such as system suitability, specificity, accuracy, precision (intra-day and inter-day), robustness, and sensitivity were conducted in accordance with ICH guidelines, confirming the reliability and reproducibility of the method. Recovery studies showed results within the acceptable range, indicating no interference from excipients. The proposed method is suitable for routine analysis of Tinidazole in both bulk drug and pharmaceutical formulations due to its simplicity, sensitivity, and cost-effectiveness.