Development and validation of a stability-indicating HPTLC method ...

Dinesh Kumar Jain et al., Int J Pharm Biomed Sci 2011, 2(2), 55-60ng /band for LOR and PCM respectively. Different validationparameters for the proposed HPTLC method are summarizedin Table 2.There were no indications of compound instability insample solutions containing concentrations 400 and 600ng/band for LOR and 100 and 200 ng/band for PCM storedfor up to 24 h.Six replicate determinations were performed on thecommercially available tablet. For LOR and PCM recoverywas found to be 99.75±0.0642% and 99.71±0.189%,respectively for HPLC and for HPTLC the spots of Rf 0.23and 0.60 were observed in chromatograms obtained fromdrug samples extracted from tablets. There was Nointerference was observed from the excipients commonlypresent in the tablets. It may, therefore, be inferred thatdegradation of LOR and PCM had not occurred in themarketed formulations analysed by this method. The lowRSD indicated that the method is suitable for routinesimultaneous estimation of LOR and PCM in pharmaceuticaldosage forms. The content and percentage of LOR and PCMin market samples are presented in Table 3.Drug recovery at the level of 89.23 % and 96.02 % forLOR and PCM respectively, from the acid-stressed samples(Fig.4), indicated significant degradation in acidic condition(Table 4). Drug recovery from base- stressed sample 79.0 %and 76.05 % for LOR and PCM respectively (Table 4). Thedifferent R f value obtained from acid and base induceddegradation product indicates that the acid degradationproducts are different from alkaline degradation product. Thechromatogram treated with 10 % (v/v) H 2 O 2 revealed peaksfor LOR and PCM (Table 4). Drug recoveries were found tobe 74.34 % and 75.14 % for LOR and PCM respectively.Drug recovery was found to be 45.2 % and 13.53 % for LORand PCM respectively, from samples of the photochemicaldegradation study, suggestion significant degradation(Table4). Significant degradation was also evident in dry heatsamples. Drug recovery was found to be at the level of 99.67% and 93.75 % for LOR and PCM respectively [9, 11].4. CONCLUSIONSThe proposed HPTLC and HPLC methods were found tobe simple, fast, accurate, precise, and sensitive. Thus, it maybe used for routine analysis of LOR and PCM in combinedtablet dosage form.ACKNOWLEDGMENTSThe authors wish to express their gratitude to Glen markpharmaceutical ltd., Mumbai and for gratis samples ofLornoxicam and Paracetamol. The authors are thankful toDirector, SICART, Vallabh Vidyanagar, Gujarat foranalytical facilities.REFERENCES[1] Altun ML. HPLC method for the analysis of paracetamol, caffeine anddipyrone. Turk J Chem 2002, 26, 521-528.[2] Akay C, Degim T, Sayal A, Aydin A, Ozakan Y, Gul H. Rapid andsimultaneous determination of acetylsalicylic acid, paracetamol andtheir degradation and toxic impurity products by hplc in pharmaceuticaldosage forms. Turk J Med Sci 2008, 38, 167–173.[3] Shirkhedkar AA, Shaikh AM, Surana SJ. Simultaneous determination ofparacetamol and piroxicam in tablets by thin layer chromatographycombined with densitometry. Eurasian J Anal Chem 2008, 2, 258-267.[4] Kwiecien A, Krzek J, Biniek L. TLC determination of azithromycin inpharmaceutical preparations. J Planar Chromatogr 2008, 21, 177-181.[5] Bhavsar SM, Patel DM, Khandhar AP, Patel CN. Validated RP-HPLCmethod for simultaneous estimation of lornoxicam and thiocolchicosidein solid dosage form. J Chem Pharm Res 2010, 2, 563-572.[6] Cetin, I., Kocak, N., Aycan, S., C.B.U. J Sci 2009, 11, 18-23.[7] Bipin HM, Sachin BM. HPTLC densitometric analysis of candesartancilexetil and hydrochlorthiazide in tablets. J Planar Chrom Mod TLC2008, 21, 173-176.[8] Dubey, N., Dubey, N., Mehta, R.S., Saluja, A.K., J AOAC Int 2009,92(6), 1617.[9] Dubey, N., Dubey, N., Mehta, R.S., Saluja, A.K., J AOAC Int 2009,92(4), 1021.[10] Dubey N, Dubey N, Mehta RS, Saluja AK. J AOAC Int 2009, 92, 779.[11] Shethi PD. HPTLC High Performance Thin Layer Chromatography,CBS Publishers, New Delhi 1996.[12] Beckett AH. Practical pharmaceutical chemistry, CBS Publication 1997.[13] Reynolds JEF, Parfitt K, Partons AV, Sweetman SC. The ExtraPharmacopoeia 1996, Martindale, London, 82.60©2011 PharmaInterScience Publishers. All rights reserved. www.pharmainterscience.com