AJPTI_121_10_2014_novel_uv_method_rebep_Sandeep_Rajan

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Sandeep Rajan Kolli et al. Asian Journal of Pharmaceutical Technology Innovation 02 08 2014 128-132 www.asianpharmtech.com 128 Asian Journal of Pharmaceutical Technology Innovation ISSN: 2347-8810 Research Article Received on: 01-10-2014 Accepted on: 09-10-2014 Published on: 15-10-2014 Novel UV Spectrophotometric Determination of Rabeprazole Sodium In Bulk and Pharmaceutical Dosage Forms Corresponding Author: Sandeep Rajan Kolli K.Mohini Kalyani B.Lakshmi K.Vineela Sandeep Rajan Kolli C.R.R. College of Pharmacy Eluru- 534007 West Godavari DT Andhra Pradesh ABSTRACT Rabeprazole RBZ sodium is a substituted benzimidazole that inhibits gastric acid secretion and used for the treatment of erosive or ulcerative GERD DU and hypersecretory syndromes including ZES. In present work a simple sensitive accurate and economical spectroscopic method has been developed for the estimation of Rabeprazole in Bulk and its pharmaceutical dosage forms. An absorption maximum was found to be at 292 nm with the solvent system 0.05N NaOH. The drug follows Beer law in the range of 2-18 μg/ml with correlation coefficient of 0.999. The percentage recovery of Rabeprazole ranged from 99.8 to 100.2 in pharmaceutical dosage form. Results of the analysis were validated for accuracy precision LOD LOQ and were found to be satisfactory. The proposed method is simple rapid and suitable for the routine quality control analysis. Email Id- sndiprkgmail.com Key-words: Rabeprazole UV spectrophotometry Tablets estimation. Cite this article as: Sandeep Rajan Kolli K.Mohini Kalyani B.Lakshmi K.Vineela Novel UV Spectrophotometric Determination of Rabeprazole Sodium In Bulk and Pharmaceutical Dosage Forms Asian Journal of Pharmaceutical Technology Innovation 02 08 2014. C.R.R. College of Pharmacy Eluru-534007 West Godavari DT Andhra Pradesh

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Sandeep Rajan Kolli et al. Asian Journal of Pharmaceutical Technology Innovation 02 08 2014 128-132 www.asianpharmtech.com 129 INTRODUCTION Rabeprazole sodium chemically Benzimidazole derivative 2-4-3- methoxypropoxy-3-methyl2- pyridinyl methyl sulfinyl - 1H- benzimidazole sodium and it is a proton pump inhibitor that suppress gastric acid secretion by specific inhibition of the enzyme system of Hydrogen/ potassium adenosine triphosphatase H+/ K+ ATPase at the secretory surface of the gastric parietal cell and is used in the treatment of various gastric disorders such as gastric and duodenal ulcers gastro esophageal reflux disease and in pathological hypersecretory conditions 1-4 . Molecular basis of Rabeprazole RBZ reveals that it is a complex for the estimation by UV method and the –OCH3 Benzimidazole pyridine are the responsible for its therapeutic activity and quality control parameters 5 6 7 . A survey of literature also states that there was no specified reported data on UV method for the estimation of Rabeprazole. An absorbance was found to be 292 nm and the spectrum was scanned for the drug dissolved in 0.05N NaOH. MATERIALS AND METHODS Rabeprazole sodium tablets were purchased from Glaxo smithkline pharmaceuticals Ltd. Mumbai. All the reagents and chemicals used were AR grade. Spectrophotometer used was Double beam UV- Visible spectrophotometer with 10mm matched quartz cell Model- UV-1700 PHARMASPEC. Make – shimadzu Japan and Analytical balance: shimadzu Japan AX 200. Tablets REPRAL TM -20 Elder pharmaceuticals Ltd. Mumbai PARIT—20 Glaxo smithkline pharmaceuticals Ltd. Mumbai. METHOD DEVELOPMENT Preparation of standard stock solution RBZ 10 mg was accurately weighed and transferred to a 100 ml volumetric flask. It was first dissolved in 25 ml of 0.05N NaOH and sonicated for about 10-15 min. then finally made up to the volume with 0. 05N NaOH 100 μg / ml. Preparation of calibration curve From the standard stock solution fresh aliquots were pipetted out and suitably diluted with 0.05N NaOH to get final concentration in the range of 2- 18 μg /ml. The solutions were scanned under spectrum mode for 200-400 nm wavelength range and a sharp peak was obtained at 292 nm Fig-1.A calibration curve was plotted taking an absorbance on Y-axis against concentration of standard solution on X-axis Fig-2. The method was applied for known sample solution and was found to be satisfactory for the analysis of tablet dosage forms.

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Sandeep Rajan Kolli et al. Asian Journal of Pharmaceutical Technology Innovation 02 08 2014 128-132 www.asianpharmtech.com 130 Data 1 0 5 10 15 20 25 0.0 0.2 0.4 0.6 0.8 1.0 concentration absorbance Fig. 1: Spectrum of Rabeprazole in 0.05N NaOH Fig. 2: calibration curve for Rabeprazole Optical characteristics The optical characteristics such as beer’s law limit molar extinction coefficient RSD were calculated. Regression characteristics like slope intercept correlation coefficient LOD LOQ standard deviation were calculated in Table-1. METHOD VALIDATION The method was validated for different parameters like Linearity Accuracy and Precision. Linearity Fresh aliquots were prepared from the stock solution 100 μg/ml ranging from 2-20 μg/ml. The samples were scanned in UV-Visible spectrophotometer using 0.05N NaOH as blank. It was found that the selected drug shows linearity between the 2-18 μg/ml. Accuracy Accuracy of the method confirmed by studying recovery at 3 different concentrations 80 100 and 120 of these expected in accordance with ICH guidelines by replicate analysis n6. Standard drug solution was added to a pre analyzed sample solution and percentage drug content was measured. The results from study of accuracy were reported in table no.3. Recovery ct –cu/ ca × 100. Where ct is the total conc. of the analyte found cu is the conc. of the analyte present in formulation and ca is the conc. of the pure analyte added to the formulation. Precision Precision intra-day precision of the method was evaluated by carrying out the six independent test samples of Rabeprazole. The intermediate precision inter-day precision of the method was also evaluated using two different analyst and different days in the same laboratory. The percent relative standard deviation RSD and assay values obtained by two analysts were found to be Good. RESULTS AND DISCUSSIONS From the optical characteristics Table-1 of the proposed method Rabeprazole was shown its λ max at 292 nm in the solvent 0.05N NaOH with a good correlation coefficient 0.9999. The percentage purity and relative standard deviation from the Assay of the tablet dosage forms Table-2 were found to be within the limits and from linearity data Table-3 it was found to be that Rabeprazole obeys beer’s

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Sandeep Rajan Kolli et al. Asian Journal of Pharmaceutical Technology Innovation 02 08 2014 128-132 www.asianpharmtech.com 131 law in the range of 2-18 μg / ml. The accuracy data of the drug Table-4 was shown good percentage recovery and RSD with the range of 99.4 -101.3 and 0.2-0.4 respectively. The Inter-day and Intra- dayTable-5 precision values were found to be 0.57 and 0.79 respectively which indicates that the proposed method is accurate and also reveals that there is no interference of the commonly used excipients and additives in the formulation. Table 1: Optical characteristics and precision of the proposed method Parameter Value Absorption maximun 292 nm Beer’s law limit μg/ml 0.9999 Regression equation Y mX+c Y 0.043x -0.002 Slope m 0.04318 Intercept c 0.00258 Standard Deviation 0.0075 LOD μg / ml 1.53 LOQ μg / ml 4.63 Table 2: Assay of Rabeprazole tablets Dosage form Label claim mg/tab Amount found ± SD Purity of the tablet ±RSD REPRAL 20 20.04 ± 0.07211 100.2 ± 0.36 PARIT 20 19.93 ± 0.055 99.85 ± 0.28 Table 3: Linearity of Rabeprazole in working standard S.No Concentration Absorbance 1 0 0. 2 2 0.085 3 4 0.17 4 6 0.259 5 8 0.342 6 10 0.428 7 12 0.519 8 14 0. 596 9 16 0. 689 10 18 0. 768 11 20 0.872 Table 4: Accuracy data of the drug Sample ID Concentration μg /ml Recovery ± S.D RSD Pure drug drug Formulation 80 8 10 101.3±0.308 0.305 100 10 10 99.4±0.397 0.40 120 12 12 99.9±0.222 0.223 CONCLUSION The proposed method for the estimation of Rabeprazole was found to be simple sensitive and reliable with good precision and accuracy. The method is specific while estimating the commercial formulations

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Sandeep Rajan Kolli et al. Asian Journal of Pharmaceutical Technology Innovation 02 08 2014 128-132 www.asianpharmtech.com 132 without interference of excipients and other additives. Hence this method can be used for the routine analysis of Rabeprazole in pure and pharmaceutical formulations. Table 5: Precision of the Rabeprazole working standards Assay of Rabeprazole as percent of labeled amount Sample no Analyst –I Intra-day precision Analyst –II Inter-day precision 1 100.32 99.78 2 101.32 101.52 3 99.88 100.36 4 100.22 101.24 5 99.98 99.87 Mean 100.34 100.54 RSD 0.57 0.79 REFERENCES 1. Richardson P Hawkey C and Stack W. Proton pump inhibitors- pharmacology and rationale for use in gastrointestinal disorders. Drugs. 1998563:307-35. 2. Feret B Quercia R and Cappa J. Micromedex- Drugdex Evaluations. Rabeprazole: A proton pump inhibitor for the treatment of acid-related disorders. Formulary. 199934:313-23. 3. Reilly JP. Safety profile of the protonpump inhibitors. Am J Health Syst Pharm 19995623 suppl 4:S11-7. 4. Titusville NJ. Rabeprazole Aciphex. Package insert. Janssen Pharmaceutica 1999. Retrieved May 2002: http://us.janssen.com/products/pi_files/aci 8.5x11.pdf. 5. Patel PM Desai HJ Patel RC and Patel NM. Spectrophotometric method for estimation of rabeprazole. Indian J Pharm Sci. 200769:318-20. 6. Wahbi AAM Abdel-Razak O Gazy AA Mahgoub H and Moneeb MS. Spectrophotometric determination of omeprazole lansoprazole and pantoprazole in pharmaceutical formulations. J Pharm Biomed Anal. 200230:1133-1142. 7. Castro D Moreno MA Torrado S and Lastres JL. Comparison of derivative spectrophotometric and liquid chromatographic methods for the determination of omeprazole in aqueous solutions during stability studies. J Pharm Biomed Anal. 199921:291-298.

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