| API |
0.1 M HCl |
0.1 M NaOH |
/ |
3% H2O2
|
60 °C |
Metal halide, mercury, xenon or UV-B fluorescent lamp |
WHO, 2005 |
| API |
0.1 M HCl, 40 or 60 °C |
0.1 M NaOH, 40 or 60 °C |
H2O, 40 or 60 °C |
3% H2O2, 25 or 60 °C |
60 or 80 °C |
Illumination ≥ 1,2·106lx h, UV light ≥ 200 Wh m−2
|
Blessy et al., 2014Blessy M, Patel R, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs-A review. J Pharm Anal. 2014;4(3):159-165.
|
| API |
0.1-1 M HCl or H2SO4
|
0.1-1 M NaOH or LiOH or KOH |
/ |
3% H2O2
|
> 50 °C |
Illumination ≥ 1,2·106lx h, UV light ≥ 200 Wh m−2
|
Alsante et al., 2007Alsante KM, Ando A, Brown R, Ensing J, Hatajik TD, Kong W et al. The role of degradant profiling in active pharmaceutical ingredients and drug products. Adv Drug Deliv Rev. 2007;59(1):29-37.
|
| Abacavir sulphate |
1 M HCl, 80 °C |
1 M NaOH, 80 °C |
H2O, 80 °C |
3% H2O2, 6% H2O2, 1.5 mM AIBN |
100 °C |
UV light (320 nm) |
Rao et al., 2011 |
| Fingolimod |
3 M HCl |
0.1 M NaOH |
H2O, 80 °C |
30% H2O2, room t
|
90 °C |
Illumination ≥ 1,2·106lx h, UV light ≥ 200 Wh m−2
|
Patel et al., 2015Patel PN, Kalariya PD, Gananadhamu S, Srinivas R. Forced degradation of fingolimod: Effect of co-solvent andcharacterization of degradation products by UHPLC-Q-TOF-MS/MS and 1H NMR. J Pharm Biomed Anal. 2015;115:388-394.
|
| Nepafenac |
0.1 M HCl, 25 °C |
0.1 M NaOH, 25 °C |
/ |
30% H2O2, 25 °C |
80 °C |
Illumination ≥ 1,2·106lx h, UV light ≥ 200 Wh m−2
|
Runje et al., 2016Runje M, Babić S, Meštrović E, Nekola I, Dujmić-Vučinić Ž, Vojčić N. Forced degradation of nepafenac: Development and validation of stability indicating UHPLC method. J Pharm Biomed Anal. 2016;123:42-52.
|
| Zofenopril |
1 M HCl, 80 °C |
1 M NaOH, 80 °C |
H2O, 80 °C |
3% H2O2, 6% H2O2, room t
|
100 °C |
UV light (320 nm) |
Ramesh, Rao, Rao, 2014Ramesh T, Rao PN, Rao RN. LC-MS/MS characterization of forced degradation products of Zofenopril. J Pharm Biomed Anal. 2014;88:609-616.
|
| Ezetimibe |
0.1 M HCl, 80 °C |
0.1 M NaOH, room t
|
H2O, 80 °C |
3% H2O2
|
80 °C |
4500 lx |
Luo et al., 2015 |
| Zolpidem tartrate |
1 M HCl, room t
|
0.1 M NaOH, room t
|
H2O, room t
|
10% H2O2, room t
|
70 °C |
Illumination ≥ 1,2·106lx h, UV light ≥ 200 Wh m−2
|
Malešević et al., 2014Malešević M, Živanović L, Protić A, Radišić M, Laušević M, Jović Z, et al. Stress degradation studies on zolpidem tartrate using LC-DAD and LC-MS methods. Acta Chromatogr. 2014;26(1):81-96.
|
| Rabeprazole |
0.01 M HCl, room t
|
2 M NaOH, 80 °C |
H2O, 80 °C |
3% H2O2, room t
|
80 °C |
Illumination ≥ 1,2·106lx h, UV light ≥ 200 Wh m−2
|
Bhandi et al., 2016Bhandi MM, Borkar RM, Shankar G, Raut S, Nagesh N, Srinivas R. Identification and characterization of stressed degradation products of rabeprazole using LC-ESI/MS/MS and 1H-NMR experiments: in vitro toxicity evaluation of major degradation products. RSC Adv. 2016;6:10719-10735.
|
| Atorvastatin calcium and celecoxib |
1 M HCl 70 °C |
1 M NaOH 70 °C |
/ |
30% H2O2, 70 °C |
100 °C |
Direct sunlight |
Jadhav, Jamkar, Avachat, 2015Jadhav P, Jamkar P, Avachat A. Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC. Braz J Pharm Sci. 2015;51(3):653-661.
|
