Application of Stability-Indicating RP-TLC Densitometric Determination of Rabeprazole Sodium in Bulk and Pharmaceutical Formulation
More details
Hide details
R. C. Patel College of Pharmacy, Department of Pharmaceutical Chemistry, Shirpur, Dist: Dhule(M.S.) India
Atul A. Shirkhedkar   

R. C. Patel College of Pharmacy, Department of Pharmaceutical Chemistry, Shirpur, Dist: Dhule(M.S.) India
Publish date: 2017-10-06
Eurasian J Anal Chem 2009;4(1):87–97
A simple, sensitive, selective, precise and stability- indicating reversed-phase thin layer chromatography (RP-TLC) densitometric determination of rabeprazole sodium as bulk and from pharmaceutical formulation have been developed and validated as per International Conference on Harmonisation (ICH) guidelines. The method employed RP-TLC aluminium plates precoated with silica gel 60 RP-18 F-254 S as the stationary phase. The mobile phase consisted of acetone: water (3.5:1.5 v/v). The system was found to give compact spot for rabeprazole sodium (Rf value of 0.45 ± 0.02). Densitometric detection was carried out at λ = 284 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r = 0.9998 in the working concentration range of 400 – 2400 ng spot -1. The method was validated for precision, accuracy, ruggedness, robustness, specificity, recovery, limit of detection (LOD) and limit of quantitation (LOQ). The LOD and LOQ were found to be19.89 and 60.29 ng per spot, respectively. The drug was subjected to acid and alkali hydrolysis, oxidation, dry heat and photodegradation, all the peaks of the degradation products were well resolved from the standard drug with significantly different Rf values. Statistical analysis proves that the developed RP- TLC densitometry method is reproducible and selective. The developed RP-TLC densitometric method can be applied for identification and quantitative determination of rabeprazole sodium in bulk drug and tablet formulation.
The Merck Index ((2006), Merck Research Laboratories division of Whitehouse station NJ, USA,. 14th ed., pp.1392.
Morri M, Takeguchi N, (1993),Different biochemical modes of action of two irreversible H+, K+-ATPase inhibitors omeprazole and E3810. J Biol Chem 268 21553 –21559.
Goodman and Gilman’s The Pharmacological Basis of therapeutics (2001), 10th ed. Mc Graw Hill Medical Publishing division New York pp.1007.
Fujisaki H, Shibata H, Oketani K, Murakami M, (1991) Effect of the proton pump inhibitor E3810 on gastric secretion and gastric and duodonal ulcer or erosins in rats. Drug Invest. 3 328 – 332.
Yong Zhang, Xiaoyan Chen, Qi Gu and Dafang Zhong, (2004) Quantification of rabeprazole in human plasma by liquid chromatography-tandem mass spectrometry . Anal Chem Acta523(2),171-175.
Ramakrishna N V S., Vishwottam K N, Wishu S, Koteshwara M and Suresh Kumar S, (2005) High performance liquid chroamtography method for the quantification of rabeprazole in human plasma using solid phase extraction. J Chromatogr B 816 (1-2), 209-214.
Mehta D R, Mehta R S, Bhatt K K, Shankar M B, (2005) RP-HPLC method for estiamtion of rabeprazole sodium in bulk and in tablet dosage form. Indian Drugs 42 (1), 39-42.
Kulkarni V L, Mahulikar P P, (2006) Estimation of rabeprazole sodium in tablet dosage form by rapid isocratic reverse phased high performance liquid chromatography using volatile buffer additives. J Sci & Ind Res 65 (12), 992-994.
Patel B H, Suhagia B N, Patel M M and Patel J R, (2007) Determination of pantoprazole,rabeprazole, esomeprazole,domperidone and itopride in pharmaceutical products by reverse phase liquid chromatography using single mobile phase.Chromatogr 65 (1-2), , 743-748.
Alaa El-Gindy, Fawzy El-Yazby and Moustafa M. Maher, (2003) Spectrophotometric and chromatographic determination of rabeprazole in presence of its degradation products. J Pharm Biomed Anal 31 (2), 229-242.
Cassia V, Garcia A, Norma S, Nudelmanb, Martin Steppe, Elfrides E S, Schapoval, (2008) Structural elucidation of rabeprazole sodium photodegradation products. J Pharm Biom Anal 46, 88–93.
Ganta Madhusudhan Reddy, Vijaya B B, Reddy P P, Sudhakar P, Moses B J, Vyasb K, Reddy R P, Mukkanti K, (2007) Identification and characterization of potential impurities of rabeprazole sodium. J Pharm Biomed Anal 43 1262–1269.
Garcia C V, Sippel, J, Sfair, L L, Garcia, S S, Jablonski A, Steppe M, Schapoval E E S, (2005) Validation of capillary electrophoresis method for analysis of rabeprazole sodium in phamraceutical dosage form.J AOAC Int 88 (4 ),1081.
Patel B H, Suhagia B N, Patel M M and Patel J R, (2008) HPTLC determination of rabeprazole and domperidone in capsules and its validation. J Chromatogr Sci 46 (4), 304-307.
Patel R D, Bhatt K K, Nakarani N V ,Shankar M B,Mehta R S, Bhatt H S,(2007), Simultaneous HPTLC estimation of rabeprazole sodium and domperidone in Capsule dosge form. Indian Drugs, 44(5), 337- 341.
Garcia C V, Sippel , Steppe M, Schapoval E S, (2006) Development and validation of derivative spectrophotometric method for determination of rabeprazole sodium in pharmaceutical formulation. Anal Lett 39 (1-3), 341-348.
Pillai S, Singhvi I, (2006) Application of orange G dye for quantitation of citalopram hydrobromide, donepezil hydrochloride and Rabeprazole Sodium from Tablet Formulation. Indian J Pharm Sci 68 ( 5), 682-.684.
Patel P M, Desai H J, Patel N M, (2007) Spectrophotometric method for estiamton of rabeprazole. Indian J Pharm Sci 69(2), 318-320.
Torıbio L, Nozal M J, Bernal J L, Jimenez A, (2005) Semipreparative chiral supercritical fluid chromatography in the fraction of lansoprazole and two related antiulcer drugs enantiomers. J Chromatogr A 1091: 118–123.
Miura M, Tada H, Satoh S, Habuchi T, Suzuki T, (2006),Determination of rabeprazole enantiomers and their metabolites by high performance liquid chromatography with solid phase extraction. J Pharm. Biomed Anal 41, 565–570.
International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceutical for Human Use (2005) Validation of analytical procedures: text and methodology Q2 (R1), pp 1-13.
International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceutical for Human Use (2003) Stability testing of new drugs substance and products Q1A (R2), pp 1-18.
Bakshi M, Singh S, (2002), Development of validated stability indicating assay methods. J Pharm. Biomed Anal 28, 1011-1040.
Sethi P D, (1996), HPTLC: Quantitative Analysis of Pharmaceutical formulation,CBS Publications, New Delhi, pp.162-165.
British Pharmacopoeia, Vol. II, HMSO, Cambridge, International edn, (2002) Appendix-112(IB).