Analytical Method Development and Validation for Telmisartan, Chlorthalidone and Amlodipine by UV- Spectroscopic Method.

Author(s):  
Rutuja M. Sanap ◽  
Sarika R. Wavhale ◽  
Vaibhavi V. Kunjir ◽  
Rajkumar V. Shete

A simple, sensitive and accurate UV- spectrophotometric absorption correction method has been developed for simultaneous determination of Telmisartan, Amlodipine and Chlorthalidone in combined tablet dosage form. Analytical method development and validation plays important role in the discovery manufacture of pharmaceuticals and development. In this paper, absorption correction method is used for multi-component analysis. The wavelengths selected for the analysis were 311nm for Telmisartan, 228nm for Chlorthalidone and 253nm for Amlodipine. Beer’s law obeyed the concentration range of 2-10 µg /ml, 2-10 µg /ml and 5-25 µg/ ml for Telmisartan, Amlodipine and Chlorthalidone. Methanol is used as a solvent. The accuracy of the method was assessed by recovery studies and was found between the range of 100% to 110% for Telmisartan, 85% to 110% for Amlodipine and 85% to 105% Chlorthalidone. The % RSD value was found to be less than 2. Thus, the method was simple, precise, economic, rapid, accurate and can be successfully applied for simultaneous determination of Telmisartan, Amlodipine and Chlorthalidone in combined tablet dosage form.

Author(s):  
Krishna Kishore Adireddy ◽  
Srinivasa Rao Baratam ◽  
Nagarjuna Hari Pratap S

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of Istradefylline in table dosage form. Chromatographic analysis of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of 0.1 % orthophosphoric acid and acetonitrile in the ratio of 30: 70 v/v. The method showed a good linear response in the concentration range of 10-90 μg/ml with correlation coefficient of 0.9993. The flow rate was maintained at 1.0 ml/min and detection was carried out at 246 nm. The retention time was 3.125 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of istradefylline in tablet formulation.


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