среда, 13 февраля 2008 г.

High performance thin layer chromatographic estimation of lansoprazole and domperidone in tablets

Mobile phaseposition was n-butanol:glacial acetic acid:water (9. Densitometric analysis of lansoprazole and domperidone was carried out in the absorbance mode at 288 nm.R f values of lansoprazole and domperidone were found to be 0.0.The limit of detection for lansoprazole and domperidone were found to be 10 and 30 ng/spot, respectively.Limit of quantification for lansoprazole and domperidone were found to be 40 and 65 ng/spot, respectively.Of drug present in the tablet and recovery studies were also carried out.Method was validated for precision, accuracy and reproducibility.Domperidone, high performance thin layer chromatography HOW TO CITE THIS ARTICLE: Susheel JV, Lekha M, Ravi TK.Performance thin layer chromatographic estimation of lansoprazole and domperidone in tablets.Pharm Sci 2007;69:684-6 HOW TO CITE THIS URL: Susheel JV, Lekha M, Ravi TK.Performance thin layer chromatographic estimation of lansoprazole and domperidone in tablets.Pharm Sci ;69:684-6.From: Lansoprazole (L), 2-({3-methyl-4-(2, , 2-trifluoroethoxy)-2-pyridyl)methyl} sulfinyl benzimidazole, is used as a gastric proton pump inhibitor.5-chloro-1-{14-piperidyl}benzimidazolin-2-one, is a dopamine antagonist and is used as antiemetic and for the treatment of nausea.These drugs, L (30 mg) and D (30 mg) is availablemercially as Lans-Dx.Have been reported for the determination of L and D, individually ,,,,,,,, .No high performance thin layer chromatographic (HPTLC) method is reported for the simultaneous determination of these drugs.Present work describes a simple, precise and accurate HPTLC method for simultaneous estimation of L and D inbined dosage forms.And D were obtained as gift samples from Natco Pharmaceuticals Ltd.India.Chemicals and reagents used were of analytical grade and purchased from S.Fine Chemicals, Mumbai.Used for the analysis was a Camag HPTLC system (with TLC scanner 3, Win CATS Software and Linomat 5 as application device).Samples were spotted in the form of bands of width 6 mm with a Hamilton syringe on precoated silica gel aluminium plate 60 F 254 (Machery-Nagel, Germany).Mobile phase consisted of n- butanol:glacial acetic acid:water (9.0.Linear ascending development of chromatogram was carried out in a Camag twin trough glass chamber saturated with the mobile phase.Chamber saturation time for mobile phase was optimized at 25 min.Length of chromatogram run was 85 mm.To development, the TLC plates were dried in a current of air.Scanning was performed using Camag TLC Scanner 3 in the absorbance mode at 288 nm.Of radiation utilized was deuterium lamp.Standard stock solution containing 0.Of L and 0.Of D were prepared by dissolving L and D in methanol.The fixed chromatographic conditions 1, 2, 3, 4 and 5 µl of standard solution were applied on plate.Plate was developed and scanned as mentioned above.Curves for L and D were generated by plotting peak areas of drugs versus concentration of drugs spotted.Each containing quantity equivalent to 10 mg of L and 10 mg of D were weighed; powdered and average weight was calculated.To 10 mg of L and 10 mg of D were weighed accurately, transferred to a 100 ml volumetric flask.Drugs were extracted with the addition of little quantities (20 ml) of methanol and volume was made upto 100 ml.Solution was filtered from which suitable aliquots were applied.Plate was developed and scanned as mentioned above .Areas were recorded and the amount of L and D present in formulations were estimated using the calibration curve for L and D.Of analysis of formulation are tabulated in .Was validated for specificity precision and accuracy.Method was found to be specific, since it resolved the peak of L (R f value= 0.D (R f value= 0.Presence of excipients in the formulations.Linear regression data showed good linear relationship over a concentration range of 100-500 ng/spot for L (r= 0.100-500 ng/spot for D (r= 0.The regression equation and validation parameters are given in .Studies were carried out and the parameters studied were intra-day precision, inter-day precision, repeatability of measurement and repeatability of sample application.% RSD.Indicate that the developed method has good precision .Studies were carried out for the plate and the developed plate was found to be stable for about 2 h.The method was evaluated by carrying out the recovery studies.Studies were carried out at 50 and 100% levels.Recovery values indicate that the method is free from interference and excipients present in formulation .HPTLC technique is precise, specific and accurate.No interference from the excipients used in the tablet formulation and hence this method can be used for routine analysis of L and D inbined dosage form.May also be extended for simultaneous analysis of L and D in plasma and other biological fluids.The authors acknowledge M/s SNR and Sons Charitable Trust, Coimbatore, India for providing the facilities to carry the experiment, Natco Pharmaceuticals Ltd.For supplying pure sample of L and D and Tamil Nadu Pharmaceutical Sciences Welfare Trust, Chennai for awarding Scholarship for the work.References Parfitt K, editor.Theplete drug reference.London; 1999.Gerloff J, Mignot A, Barth H, Heintze K.And absolute bioavailability of lansoprazole.J Clin Pharmacol 1996;50:293-7.Masatomo M, Tada H, Suzuki T.Determination of lansoprazole enantiomers and their metabolites in plasma by liquid chromatography with solid-phase extraction.Chromatogr B Analyt Technol Biomed Life Sci 2004;804:389-95.Pandya KK, Mody VD, Satia MC, Modi RI, Chakravarthy BK, Gandhi TP.Thin-layer chromatographic method for the detection and determination of lansoprazole in human plasma and its use in pharmacokinetic studies.B Biomed Sci Appl 1997;693:199-204.Wu MS, Gao L, Cai XH, Wang GJ.Of domperidone in human plasma by LC-MS and its pharmacokinetics in healthy Chinese volunteers.Pharmacol Sin 2002;23:285-8.Zavitsanos AP, MacDonald C, Bassoo E, Gopaul D.Of domperidone in human serum and human breast milk by high performance liquid chromatography-electrospray mass spectrometry.Chromatogr B Biomed Sci Appl 1999;730:9-24.Trivedi C, Soni K, Khan IJ, Loya P, Manglani U, Saraf MN.Chromatographic analysis with ultra violet detection for the determination of domperidone in human plasma.Drugs 2005;42:461-4.Vinodhini C, Vaidyalingam V, Ajithadas A, Niraimathi V, Shantha A.Of cinnarizine and domperidone in solid dosage form by high performance liquid chromatographic method.Drugs 2005;42:516-8.Vinodhini C, Vaidyalingam V, Kalidoss AS.Estimation of cinnarizine and domperidone by high performance thin layer chromatographic method in tablets.Drugs 2005;42:600-3.Kobylinska M, Kobylinska K.
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