Telmisartan Quality Control by Validation of UV-Spectrophotometric Method

The aim of current study was to validate spectrophotometric method with UV-detection for identification and determination of Telmisartan in 99.8 % ethanol in respect of analytical parameters: selectivity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy and precision (repeatability). For Telmisartan in 99.8 % еthanol at λ max = 298 nm for A^1%_1cm and ε the obtained results for А > 0.2 and А < 0.2 are:

1) А > 0.2: at 3.10^–6 g/ml ÷ 1.25.10^–5 g/ml; A^1%_1cm: 725 ÷ 823; ε: 37347 ÷ 42335
2) А < 0.2: at 2.5.10^–7 g/ml ÷ 1.10^–6 g/ml; A^1%_1cm: 1201 ÷ 1567; ε: 61816 ÷ 80651

Analytical parameter accuracy is represented by the degree of recovery, which in the corresponding confidence possibility suit the confidence interval: R С_Т60: 100.31 % ÷ 102.05 %; R С_Т80: 99.22 % ÷ 103.18 %; R С_Т100 : 93.58 % ÷ 101.9 %. For precision is proved that all results for the quantities correspond to the relevant confidence interval: С_Т60: 60.31 mg ÷ 60.77 mg; С_Т80: 79.82 mg ÷ 82.18 mg; С_Т100: 94.22 mg ÷ 101.58 mg.