DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING HPLC METHOD FOR THE ESTIMATION OF RABEPRAZOLE IMPURITIES IN PHARMACEUTICAL DOSAGE FORMS BY DESIGN OF EXPERIMENTS
Keywords:
Rabeprazole, QbD approach, Degradation Products, Stability-Indicating, ICH GuidelinesAbstract
A novel stability-indicating reverse phase liquid chromatographic method was developed for the determination of Rabeprazole impurities in Rabeprazole tablet formulations. One unknown impurity was isolated and characterized by using MS and NMR, which was formed in the formulated drug stability study. Rabeprazole was subjected to the stress conditions like oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Chromatographic separation was achieved on HPLC in gradient elution mode by QbD-approach. The eluted compounds were monitored at 280 nm. All the impurities and degradation products were well resolved from the main peak, proving the stability-indicating power of the method. On the basis of spectral data, the unknown impurity was characterized as 1-(1H -Benzimidazol-2-yl)-4-(3-methoxypropoxy)-3-methylpyridinium-2-carboxylate. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and ruggedness
Keywords: Rabeprazole, QbD approach, Degradation Products, Stability-Indicating, ICH Guidelines
Downloads
References
Richardson P, Hawkey C, Stack W. Proton pump inhibitors- pharmacology and rationale for use in gastrointestinal disorders. Drugs 1998; 56: 307-35.
Feret B, Quercia R, Cappa J. Micromedex- Drugdex Evaluations. Rabeprazole: A proton pump inhibitor for the treatment of acid-related disorders. Formulary 1999; 34: 313-23.
Reilly JP. Safety profile of the protonpump inhibitors. Am J Health Syst Pharm 1999; 56: S11-7.
The Merck Index. Merck and Co., Inc., Whitehouse Station, NJ. 1996; pp 1392.
Barth J, Hahne W. Rabeprazole based therapy in Helicobacter pylori eradication. Aliment Pharmacol Ther 2002; 16: 31–33.
Kommanaboyina B, Rhodes CT. Trends in stability testing, with emphasis on stability during distribution and storage. Drug Dev Ind Pharm 1999; 25: 857–868.
Cassia VG, Norma SN, Martin S, Elfrides ESS. Structural elucidation of rabeprazole sodium photodegradation products. J PharmBiomed Anal 2008; 46: 88-93.
Janssen-Cilag. Pariet® –Rabeprazole, 1999.
Mathew M, Das Gupta V, Bailey R. Stability of omeprazole solutions at various pH values as determined by high-performance liquid chromatography. Drug Dev Ind Pharm 1995; 21: 965–971.
Radi A. Adsorptive stripping square-wave voltammetric study of the degradation of lansoprazole in aqueous solutions. Microchem J 2002; 73: 349–354.
Qaisi A, Tutunji M, Tutunji L. Acid Decomposition of Omeprazole in the Absence of Thiol: A Differential Pulse Polarographic Study at the Static Mercury Drop Electrode (SMDE). J Pharm Sci 2006; 95: 384–391.
Vadas EB, Genaro ARR. The Science and Practice of Pharmacy, 20th ed., Lippincott Williams & Wilkins. Philadelphia 2000; 980–985.
Garcia CV, Nudelman NS, Steppe M, Schapoval EES. Structural elucidation of rabeprazole sodium photo degradation products. J Pharm Biomed Anal 2008; 46: 88–93.
Reddy GM, Bhaskar BV, Reddy PP, Sudhakar P, Babu JM, Vyas K, Reddy PR, Mukkanti K. Identification and characterization of potential impurities of rabeprazole sodium. J Pharm Biomed Anal 2007; 43: 1262–1269.
Pingili RR, Jambula MR, Ganta MR, Ghanta MR, Sajja E, Sundaram V, Boluggdu VB. Identification and synthesis of potential impurities of Rabeprazole sodium. Pharmazie 2005; 60: 814–818.
Reddy GM, Mukkanti K, Bhaskar BV, Reddy PP. Synthesis of metabolites and related substances of rabeprazole, an anti-ulcerative drug. Synth Commun 2009; 39: 278–290.
Reddy PR, Himabindu V, Jayadeepkumar L, Reddy GM, Kumar JV, Reddy GM. An improved process for the production of rabeprazole sodium substantially free from impurities. Org Process Res Develop 2009; 13: 896–899.
Buchireddy R, Mukkanti K, Srinivasulu P, Srinivas KSV. A Validated Stability-Indicating, LC Method for Rabeprazole Sodium. Chromatographia 2008; 68: 275-280.
Srinivas KSV, Buchireddy R, Mukkanti K, Srinivasulu P. A Validated RP-LC Method for Advanced Intermediate of Rabeprazole Sodium. Chromatographia 2009; 69: 381-384.
Shan Ren, Mi-Jin Park, Hongkee Sah, Beom-Jin Lee. Effect of pharmaceutical excipients on aqueous stability of rabeprazole sodium. Int J Pharm 2008; 350: 197-204.
Kulkarni VL, Mahulikar PP. Estimation of Rabeprazole Sodium in tablet dosage form by rapid isocratic reversed phase high performance liquid chromatography using volatile buffer additives. J Sci Ind Res 2006; 65: 992-994.
Halder A, Mandal BK, Sridevi R, Navalgund SG. Validated RP-HPLC method for rabeprazole and its stability studies. NSHM J Pharm Healthcare Manage 2011; 02: 76-82.
Sreenivasa Rao P, Uttam Kumar Ray, Badarinadh Gupta P, Srinivasa Rao DVN, Aminul Islam, Pradeep Rajput, Mukkanti K. Identification, isolation and characterization of new impurity in rabeprazole sodium. J Pharm Biomed Anal 2010; 52: 620–624.
Vasu Dev R, Sai Uday Kiran G, Venkata Subbaiah B, Suresh Babu B, Moses Babu J, Dubey PK, Vyas K. Identification of degradation products in stressed tablets of Rabeprazole sodium by HPLC-hyphenated techniques. Magn Reson Chem 2009; 47: 443-448.
Raja Kumar S, Raghava Raju TV, Ravindra Kumar Y, Suresh Babu B, Venkatasubbaiah B, Chakravarthy IE. Development and validation of a stability indicating UPLC method, Identification, and characterization of three degradant impurities in pharmaceutical dosage form of Rabeprazole Sodium. J Liq Chromatogr Related Technol 2013; 36: 2261-2278.
Churms SC. The essence of chromatography. J Chromatogr A 1996; 720: 151.
McBrien M. Practical implications of quality by design to chromatographic method development. Chromatography Today 2010; 3: 30-33.
ICH, Q8 (R2). Pharmaceutical Development, International Conference on Harmonization, 2009.
ICH, Q2 (R1). Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization, 2005.
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.