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Table 3 Results of forced degradation study

From: Stability-indicating RP-HPLC method development and validation for simultaneous estimation of telmisartan and rosuvastatin calcium in bulk and in tablet dosage form

Sample name/stress condition Drug substance Drug product
% Assay % Total degradation % Mass Balance % Assay % Total degradation % Mass Balance
TLS RST TLS RST TLS RST TLS RST TLS RST TLS RST
Unstressed (as per method) 99.74 98.70 ND ND 99.74 98.70 98.14 98.74 ND ND 98.14 98.74
Acid/5 N HCl/ 3 h/RT 98.72 81.82 ND 18.25 98.72 100.07 98.96 85.25 ND 15.80 98.96 101.04
Alkali/5 N NaOH/3 h/RT 99.82 98.23 ND ND 99.82 98.23 100.44 101.15 ND ND 100.44 101.15
Oxidative/6% H2O2/3 h/RT 99.16 99.87 ND ND 99.16 99.87 99.52 99.15 ND ND 99.52 99.15
Thermal/105 °C/24 h 98.94 98.19 ND ND 98.94 98.19 98.25 62.72 ND 35.05 98.25 97.77
Photolytic/UV light/24 h 99.02 95.06 ND 2.62 99.02 97..68 98.37 85.52 ND 12.09 98.37 97.61
Humidity/75% RH/ 48 h 98.69 97.91 ND ND 98.69 97.91 99.03 99.18 ND ND 99.03 99.18