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ABSTRACT:
Objective: A new rapid, simple, sensitive, selective and accurate reversed-phase stability indicating HPLC method was developed for the determination of Tolterodine Tablets 2mg. Tolterodine Tartrate used in the treatment of urinary incontinence. Method: A RP-HPLC method was developed for method development, validation as well as for the stability indication. The process was achieved using a RP-High performance liquid chromatography equipped with Auto Sampler and DAD or UV detector and the column used for process was Symmetry C18 (4.6 x 150mm, 5 µm, Make: Kromosil). The mobile phase was consists of Phosphate Buffer (with pH 3.0) and Acetonitrile [HPLC grade]. The binary gradient was made with a flow rate at 0.8 ml/min. The detection wavelength was selected 282 nm. The injection volume was 20 µL. Results: The Accuracy was calculated and the % Recovery was found to be 98.1%to 100.2%. The method was found to be Linear over the range of 20 to 100µ g per ml. The LOD for the drug was found to be 0.108µ g/ml and LOQ for Tolterodine Tartrate was found to be 0.36µg/mL. The drug undergoes degradation under Acidic, Basic, Photochemical, Thermal and Oxidation. All the peaks of the degraded products were resolved from the active Pharmaceutical Ingredient with significantly different retention time. Conclusion: The validated method yielded good results of precision, linearity, accuracy, and robustness. The proposed method was found to be suitable and accurate for the method development and validation and assay of compound Tolterodine Tartrate in active pharmaceutical ingredient. The developed method was validated to ensure the compliance in accordance with ICH guidelines and also well suitable for studies on HPLC. The method was reproducible and selective for the estimation of Tolterodine Tartrate. Because the method could effectively separate the drug from its degradation products, it was employed as a stability-indicating one.
KEYWORDS: High performance liquid chromatography, Assay, Validation, Limit of Quantification (LOQ), Tolterodine Tartrate, Limit of Detection (LOD), ICH guideline, Stability Indicating.
(ProQuest: ... denotes formulae omitted.)
INTRODUCTION:
Stability testing is used as a primary tool to determine and asses the expiration dating and storage conditions for Pharmaceutical products. Stability testing includes long-term and accelerated conditions, where the product is stored at room temperature and humidity, high heat and controlled humidity conditions. Stability study...