July 2016 ARTICLE LIST >>
PharmaTutor (July- 2016)
Print-ISSN: 2394 - 6679
e-ISSN: 2347 - 7881
(Volume 4, Issue 7)
Received On: 27/02/2016; Accepted On: 08/03/2016; Published On: 01/07/2016
AUTHORS:
S. Ashutosh Kumar*, Manidipa Debnath, Venugopal Padala,
Department of Pharmaceutical Analysis and Quality Assurance,
A.K.R.G College of Pharmacy, Nallajerla, West Godavari, A.P
*ashu.mpharm2007@gmail.com
ABSTRACT: Objective: The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC method in which the peaks will be appear with short period of time as per ICH Guidelines.
Method: The HPLC separation was achieved on an Inertsil-C18 ODS column (250 X 4.6 mm; 5 μ) column in an Isocratic Mode. The mobile phase composed of Methanol [HPLC Grade] (55 %) and Buffer (45 %) [pH 4.0 adjusted with triethylamine]. The flow rate was monitored at 1.0 mL/min. The wavelength was selected for the detection was 276 nm.
Results: The retention times found for rabeprazole and mosapride was 2.946 and 4.186 min respectively. The % recovery was 99.98- 100.03 for rabeprazole and 99.97 - 100.02 for mosapride. The linearity was established in the range of 20-80 μg/mL for both rabeprazole and mosapride. The LOD for rabeprazole and mosapride were 0.01 and 0.035 μg/mL respectively. The LOQ for rabeprazole and mosapride were 0.032and 0.11 μg/mL respectively.
Conclusion: The proposed method was adequate sensitive, reproducible, and specific for the determination of rabeprazole and mosapride in bulk as well as in tablet dosage forms.
How to cite this article: Kumar SA, Debnath M, Padala V; An Iso cratic Method Development and Validation for simultaneous estimation of Rabeprazole and Mosapride in Tablet Dosage Forms by using RP-HPLC; PharmaTutor; 2016; 4(7); 41-51
[ABSTRACT WITH CITATION] [VIEW AS HTML]
REFERENCES:
1. Carswel C. I. and Goa K L; Rabeprazole: an update of its use in acid related disorders; Drugs 2001; 61(15); 2327-2356.
2. Bhavesh Patel H., Madhabhai Patel M., Jignesh Patel R. and Bahnubhai Suhagia N; HPLC analysis for simultaneous determination of Rabeprazole and Domperidone in pharmaceutical formulation; J. Liq. Chrom. Rel. Tech. 2007; 30(3); 439-445.
3. Prasanna B. R. and Reddy M. S; Development and validation of RP-HPLC for the determination of Rabeprazole sodium in pharmaceutical formulations and human plasma; Asian J Res Chem; 2009; 2(1); 495-499.
4. Garcia CV, Paim C.S. and Steppe M; New liquid chromatographic method for determination of Rabeprazole sodium in coated tablets; J AOAC Int; 2004; 87(4); 842-846.
5. Rajesh S., Ganesh P. M., Subhash C. C; Development and validation of RP-HPLC method for the simultaneous determination of Rabeprazole sodium and Itopride hydrochloride in solid dosage form; E J Chem.; 2010; 7(3); 947-952.
6. Pillai S. and Singhvi I; Quantitative estimation of Itopride hydrochloride and Rabeprazole sodium from capsule formulation; Indian J Pharm Sci.; 2008; 70(5); 658-661.
7. Cassia Garcia V., Norma Nudelman S., Martin Steppe. and Elfrides Schapoval E.S; Structural elucidation of Rabeprazole sodium photo degradation products; J. Pharm Biomed Ana; 2008; 46(1); 88-93.
8. Patel B. H., Suhagia B. N. and Patel M. M; High-performance liquid chromatography and thin-layer chromatography for the simultaneous quantitation of Rabeprazole and Mosapride in pharmaceutical products; J Chrom Sci; 2008; 46(1); 4-10.
9. Shan Ren., Mi-Jin Park., Hongkee Sah. and Beom-Jin Lee; Effect of pharmaceutical excipients on aqueous stability of Rabeprazole sodium; Int J Pharm; 2008; 350(1-2); 197-204.
10. Osman A. O; Spectrofluorimetry, thin layer chromatography and column high-performance liquid chromatography determination of Rabeprazole sodium in the presence of its acidic and oxidized degradation products; J AOAC Int.; 2009; 92(5); 1373-1381.
11. El-Gindy A., El-Yazby F. and Maher M. M; Spectrophotometric and chromatographic determination of Rabeprazole in presence of its degradation products; J Pharm Biomed Anal. 2003; 31(2); 229-242.
12. Pattanayak P., Sharma R. and Chaturved S. C; Simultaneous spectrophotometric estimation of Rabeprazole sodium and Itopride HCl; Anal Lett; 2007; 40(12); 2288-2294.
13. Suganthi A., Sofiya J. and Ravi T. K; Simultaneous HPTLC determination of Rabeprazole and Itopride hydrochloride from their combined dosage form. Indian J Pharm Sci; 2008; 70(3); 366-8.
14. Shirkhedkar A. A. and Surana S. J; Application of stability-indicating RP-TLC densitometric determination of Rabeprazole sodium in bulk and pharmaceutical formulation; Eurasian J Anal Chem; 2009; 4(1); 165-170.
15. US Food and drug administration; Guidance for industry: Q2B validation of analytical procedures: methodology, Rockville; 1996.
16. US FDA; Guideline for industry: text on validation of analytical procedures: ICH Q2A; Rockville, MD; 1995.
17. International conference on harmonization (ICH), ICH quality guidelines: Good manufacturing practice guidance for active pharmaceutical ingredients Q7A (ICH), Geneva, Switzerland; 2001.
18. US Food and drug administration; Guidance document for industry; Analytical procedures and methods validation, FDA, Rockville, MD; 2000.
19. ICH, ICH Quality guidelines validation on analytical procedures: Methodology Q2B, ICH, Geneva, Switzerland; 1996.
20. Indian Pharmacopeia 2007; Volume I; Published by The Indian Pharmacopoeia Commission; 477-478.
.png)
