A VALIDATED RP-UPLC METHOD DEVELOPMENT FOR SIMULTANEOUS ESTIMATION OF LANSOPRAZOLE AND NAPROXEN IN BULK AND TABLET DOSAGE FORM
Abstract
Objective:Â A simple and precise RP-UPLC method development and validation for simultaneous estimation of lansoprazole (LAN) and naproxen (NAP) in bulk and tablet Dosage Form.
Method: Simple, accurate and cost efficient RP-UPLC method has been developed and validated for the simultaneous estimation of lansoprazole and naproxen in bulk and tablet dosage form. The optimum conditions for the analysis of the drug were established.
Results: The retention time (RT) was found to be 3.905 and 2.650 min for lansoprazole (LAN) and naproxen (NAP), for analysis the maximum wavelength (λmax) was found 284nm for simultaneous estimation of LAN and NAP. The method was linear and found to be range between 5-30 μg/ml (r2= 0.998) and 10-35 μg/ml (r2= 0.999) for LAN and NAP respectively. The value of limit of detection and limit of quantification was 0.8397 and 2.979 μg/ml for LAN and 0.4678 and 1.5593 μg/ml for NAP, the recovery was found between 80,100 and 120% and RSD less than 2 for LAN and NAP. The method was satisfactorily validated as per the ICH guideline.
Conclusion: The proposed methods were simple, sensitive, precise, accurate, reproducible, quick and useful for routine quality control. This study shows that the proposed RP-UPLC method is useful for the routine determination of LAN and NAP in its bulk and tablet dosage form.
Keywords: Lansoprazole, Naproxen, RP-UPLC, Method validation and TabletsÂ
Downloads
References
Yeniceli D, Dogrukol DAK, Tuncel M: Determination of lansoprazole in pharmaceutical capsules by flow injection analysis using UV-detection. J Pharma Biomed Anal 2004;36 :145–148.
Haque T, Md.Talukder MU, Laila S, Fatima K: Development and validation of a RP-HPLC method for simultaneous estimation of naproxen and ranitidine hydrochloride. Pak J Pharma Sci 2010;23 :379-383.
Aanandhi VM, Thiyagarajan N, Koilraj M, Shanmugasundaram P, Sujatha M: Simultaneous estimation of domperidone and lansoprazole in capsule formulation by HPTLC method. Rasa J Chem 2009;1:15-17.
Saudaya RB, Saraf S: First order derivative simultaneous equation curve methods for estimation of domperidone maleate and rabeprazlole sodium in tablet dosage form. Indian Drugs 2006;43:388-392.
Oliveira CH, Abib E, Barrientos ARE, Mendes GD, Da Silva DR, De Nucci G: Lansoprazole quantification in human plasma by liquid chromatography-electrospray tandem mass spectrometry. J Chromat B 2003;3:453-459.
The United States Pharmacopeial Convention. 29th Edn. Rockville: MD; 2011:2458.
Choudhary N, Siddiqui I, Rai J, Singh S, Surabhi S, Gautam H: Simultaneous estimation of lansoprazole and naproxen by using UV spectrophotometer in tablet dosage form. Der Pharma Chemica 2013;5(2):67-74.
Katsuki H, Hamada A, Nakamura C, Arimori K, Nakano M: High-performance liquid chromatographic assay for the simultaneous determination of lansoprazole enantiomers and metabolites in human liver microsomes. J Chromato B 2001;757:127–133.
Moustafa AAM: Spectrophotometric methods for the determination of lansoprazole and pantoprazole sodium sesquihydrate. J Pharma Biomed Anal 2000;22 :45-58.
Wahbi AAM, Razak AO, Mahgoub H, Azza A, Moneeb MS: Spectrophotometric determination of omeprazole, lansoprazole and pantoprazole in pharmaceutical formulations. J Pharma Biomed Anal 2002;30 :1133-1142.
Pandey M, Chawla P, Saraf AS: Simultaneous estimation of sumatriptan succinate, naproxen and domperidone by reverse phase ultra performance liquid chromatography. Asian J Pharma Clini Res 2012;5 :176-178.
Mehta P, Sharma SC, Nikam D, Ranawat MS: Development and validation of related substances method by HPLC for analysis of naproxen in naproxen tablet formulations. Int J Pharm Sci Drug Res. 2012;4:63-69.
Pawar MS, Patil SB, Patil YR: Validated HPTLC method for simultaneous quantitation of domperidone maleate and naproxen sodium in bulk drug and formulation. Eur J Anal Chem 2010;5 :284-292.
Singh S, Patel K, Agarwal VK, Chaturvedi S: Stability indicating HPTLC method for simultaneous determination of valsartan and hydrochlorothiazide in tablets. Int J Pharma Pharmac Sci. 2012;4 :468-471.
Singh S, Patel K, Agarwal VK, Chaturvedi S: Simultaneous estimation of S(-) amlodipine besylate hemipentahydrate and losartan potassium in combined dosage form by using uv-spectroscopy. Der Pharm Lett 2002;4 :897-905.
Singh S, Yadav AK, Gautam H: First order derivative spectrophotometric determination of telmisartan in pharmaceutical formulation. Bull Pharma Res 2012;2 :83-86.
Singh S, Dubey N, Jain DK: Simultaneous estimation of cefpodoxime proxetil and clavulate potassium combined dosage form using UV-Spectroscopy and reverse phase liquid chromatography. Int J Biomed Pharm Sci 2011;5 :57-60.
Singh S, Yadav AK, Gautam H: Simultaneous estimation of valsartan and hydrochlorothiazide in solid dosage form using UV spectroscopy. Bull Pharm Res 2011;1 :10-12.
Singh S, Dubey N, Jain DK: Simultaneous estimation of atorvastatin, clopidogrel and aspirin in capsule dosage forms using UV-spectroscopy. Asian J Res Chem 2010;3 : 885-887.
Pandey M, Chawla P, Saraf SA: Simultaneous estimation of sumatriptan succinate, naproxen and domperidone by reverse phase HPLC. Asian Journal of Pharmaceutical and Clinical Research 2012;5(3):176-178.
Topagi KS, Jeswani RM, Sinha PK, Damle MC: A validated normal phase HPLC method for simultaneous determination of drotaverine hydrochloride and omeprazole in pharmaceutical formulation. Asian Journal of Pharmaceutical and Clinical Research 2010;3(1):20-24.
Singh S*, Inamullah, Rai J, Choudhary N, Sharma S: Stability-indicating UV-VIS spectrophotometric method for estimation of atorvastatin calcium and fenofibrate in tablet dosage form. Bull Pharm. Research 2012;2(3):159-166.
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.