02198nas a2200181   4500008004100000022001400041245014500055210006900200260008000269300001200349490000700361520143000368100002601798700002401824700002501848700002101873856012201894       2009                        eng d  a1060-327100aApplication of a stability-indicating thin-layer chromatographic method to the determination of tenatoprazole in pharmaceutical dosage forms0 aApplication of a stabilityindicating thinlayer chromatographic m  a481 N FREDRICK AVE, STE 500, GAITHERSBURG, MD 20877-2504 USAbAOAC INTcMAR  a387-3930 v923 a<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>1 aDhaneshwar, Sunil, R.1 aBhusari, Vidhya, K.1 aMahadik, Mahadeo, V.1 aSanthakumari, B.  uhttps://library.ncl.res.in/content/application-stability-indicating-thin-layer-chromatographic-method-determination-002207nas a2200241   4500008004100000022001400041245008000055210006900135260010600204300001200310490000700322520133200329653000901661653003201670653001901702653001801721653001501739100002501754700002401779700002501803700002601828856011101854       2009                        eng d  a0731-708500aLC-UV and LC-MS evaluation of stress degradation behaviour of tenatoprazole0 aLCUV and LCMS evaluation of stress degradation behaviour of tena  aTHE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, ENGLANDbPERGAMON-ELSEVIER SCIENCE LTDcDEC  a787-7930 v503 a<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>
10aHPLC10aStability-indicating method10aStress studies10aTenatoprazole10aValidation1 aMahadik, Mahadeo, V.1 aBhusari, Vidhya, K.1 aKulkarni, Mahesh, J.1 aDhaneshwar, Sunil, R.  uhttps://library.ncl.res.in/content/lc-uv-and-lc-ms-evaluation-stress-degradation-behaviour-tenatoprazole-0