Method Development And Validation For The Determination Of Potential Impurities Present In Telmisartan And Hydrochlorothiazide In Fixed Dose Combination Drug Product By Using Reverse Phase - Ultra Performance Liquid Chromatography Coupled With Diode-Array
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Abstract
The chromatographic conditions were successfully developed for the separation of Hydrochlorothiazide and Telmisartan by using Acquity UPLC HSS T3 (100 mm x 2.1 mm), 1.8m, flow rate was 1ml/min, mobile phase ratio was ortho phosphoric acid (OPA) in water as Mobile phase-A. Acetonitrile was used as Mobile phase-B. For initial trial purpose, effect of pH was studied in the range between pH 2.2 to 3.0. Trials using 0.1% OPA buffer pH adjusted to 2.6±0.05 with diluted sodium hydroxide solution is found to be suitable for separation of impurities present in TL/HC tablets with gradient elution mode and detection wavelength was 225 nm.The Spectroscopic method was done in solvent using methanol and the instrument lab india 3000+ with uv win software. The instrument used for HPLC , WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software-2. The % purity of Hydrochlorothiazide and Telmisartan was found to be 99.87% and 100.27% respectively. The system suitability parameters for Hydrochlorothiazide and Telmisartan such as theoretical plates and tailing factor were found to be 4260, 1.2 and 5085 and 1.2, the resolution was found to be 7.67. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1))
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References
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