@article { ISI:000265309100005,
	title = {Application of a stability-indicating thin-layer chromatographic method to the determination of tenatoprazole in pharmaceutical dosage forms},
	journal = {Journal of AOAC International},
	volume = {92},
	number = {2},
	year = {2009},
	month = {MAR},
	pages = {387-393},
	publisher = {AOAC INT},
	address = {481 N FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USA},
	abstract = {<p>A sensitive, selective, precise, and stability-indicating thin-layer chromatographic (TLC) method was developed and validated for the determination of tenatoprazole both as a bulk drug and in formulation. The method uses TLC aluminum plates precoated with Silica Gel 60(F-254) as the stationary phase and the solvent system toluene-ethyl acetate-methanol (6 + 4 + 1, v/v/v). This system gave compact spots for tenatoprazole (R(f) value of 0.34 +/- 0.02). Tenatoprazole was subjected to acid and alkali hydrolysis, oxidation, and photodegradation. The peaks of the degradation products were well-resolved from that of the pure drug and had significantly different Rf values. Densitometric analysis of tenatoprazole was performed in the absorbance mode at 306 nm. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 100-1500 ng/spot. The mean values of the correlation coefficient, slope, and intercept were 0.9989 +/- 1.42, 10.27 +/- 0.965, and 4894.2 +/- 1.24, respectively. The method was validated for precision, robustness, and recovery. The limit of detection and limit of quantitation were 50 and 100 ng/spot, respectively. Statistical analysis showed that the method is repeatable and selective for estimation of tenatoprazole. Because the method can separate the drug from its degradation products, it can be used to monitor stability.</p>},
	issn = {1060-3271},
	author = {Dhaneshwar, Sunil R. and Bhusari, Vidhya K. and Mahadik, Mahadeo V. and Santhakumari, B.}
}
@article { ISI:000270759600015,
	title = {LC-UV and LC-MS evaluation of stress degradation behaviour of tenatoprazole},
	journal = {Journal of Pharmaceutical and Biomedical Analysis},
	volume = {50},
	number = {5},
	year = {2009},
	month = {DEC},
	pages = {787-793},
	publisher = {PERGAMON-ELSEVIER SCIENCE LTD},
	address = {THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLAND},
	abstract = {<p>In the present study, comprehensive stress testing of tenatoprazole was carried out according to ICH guideline Q1A (R2). Tenatoprazole was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Additionally, the solid drug was subjected to 50 degrees C for 60 days in dry-bath, and to the combined effect of temperature and humidity at 40 degrees C/75\% RH. Extensive degradation was found to occur in acidic, neutral and oxidative conditions. Mild degradation was observed in basic conditions. The drug is relatively stable in the solid-state. The products formed under different stress conditions were investigated by LC and LC-MS. Successful separation of drug from degradation products formed under stress conditions was achieved on a Chemito ODS-3 column [C(18) (5 mu m, 250 mm x 4.6 mm, i.d.)] using methanol: 0.01 M acetate buffer pH 4.5 adjusted with glacial acetic acid (55:45) as the mobile phase at flow rate of 1 mL/min and the peak was detected using a UV detector set at 306 nm. The LC-MS m/z values and fragmentation patterns of degradation products formed under different stress conditions were studied and characterized through LC-MS fragmentation. Based on the results, degradation pathway for drug has been proposed. (C) 2009 Elsevier B.V. All rights reserved.</p>
},
	keywords = {HPLC, Stability-indicating method, Stress studies, Tenatoprazole, Validation},
	issn = {0731-7085},
	doi = {10.1016/j.jpba.2009.06.026},
	author = {Mahadik, Mahadeo V. and Bhusari, Vidhya K. and Kulkarni, Mahesh J. and Dhaneshwar, Sunil R.}
}
