ABSTRACT:
A stability indicating UV spectrophotometric method has been developed and validated for the estimation of voglibose in pharmaceutical preperation. The proposed method utilized 0.1 N NaOH as solvent and detection was carried out at 214.5nm. Experiments were designed for determining linearity, limit of detection and quantitation, accuracy, precision and specificity of this analytical method. The stability studies of voglibose was carried out under acid, alkaline, thermal, oxidative and photolytic. The responses were linear in the concentration range of 5-25µg/ml with correlation coefficient of 0.9997. The % RSD for both inter-day and intra-day precision were less than 2%. The recovery of drug from sample was found to be 99.6-100.4%. Although the degradation products of stress condition had not been identified, the method had been able to detect the changes due to stress condition. The stated method can be used as stability indicating method with high degree of linearity, accuracy and precision for assay of voglibose in routine pharmaceutical analysis of tablet formulation. The method was found to be simple and cost effective. Hence this method can be successfully used to study stress degradation behavior of voglibose in small industry where high end instruments are not available.
Cite this article:
Royal Debnath, S. Y. Manjunath, T. Hemant Kumar. Stability Indicating UV Spectrophotometric method for the Determination of Voglibose in Pharmaceuticals Dosage Form. Research Journal of Pharmacy and Technology. 2022; 15(6):2543-6. doi: 10.52711/0974-360X.2022.00425
Cite(Electronic):
Royal Debnath, S. Y. Manjunath, T. Hemant Kumar. Stability Indicating UV Spectrophotometric method for the Determination of Voglibose in Pharmaceuticals Dosage Form. Research Journal of Pharmacy and Technology. 2022; 15(6):2543-6. doi: 10.52711/0974-360X.2022.00425 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2022-15-6-29
REFERENCES:
1. Maryadele JO, The Merck Index: An encyclopedia of chemicals drugs and biologicals, Merck Research Laboratories, Division of Merck Co, Inc, Whitehouse Station, Neil (Eds), New Jersey; 2006.
2. Maryadele J, Heckelaman PE, Koch CB, The Merck Index: An encyclopedia of chemicals. 14th ed. Drugs and Biologicals. Merk Research Laboratories, USA; 2006.
3. Vichayanrat A, Ploybutr S, Tunlakit M and Watanakejorn P. Efficacy and safety of voglibose in comparison with acarbose in type 2 diabetic patients. Diabetes Research and Clinical Practice. 2002 ; 5 : 99-103.
4. Satoh N, Shimatsu A, Yamada K, Aizawa-Abe M, Suganami T, Kuzuya H and Ogawa Y. An alpha-glucosidase inhibitor, voglibose, reduces oxidative stress markers and soluble intercellular adhesion molecule 1 in obese type 2 diabetic patients. Metabolism. 2006; 55 (6): 86-93.
5. Udhan RR, Jaybhaye S, Pathan IB. Development and validation of a simple UV spectrophotometric method for the determination of desloratadine both in bulk and marketed dosage formulation. International Journal of Pharmacy Research and Science. 2013;1(1):33-6.
6. Bhagyalakshami RM, Ravi TK. Development and validation of UV-spectroscopic method for estimation of voglibose in bulk and tablets. Journal of Chemical and Pharmaceutical Research . 2010;2(2):350-6.
7. Kishore VS, Kumar JP, Chakravarthy TK, Naik SV, Reddy MH and Babu EN. Development and Validation of RP-HPLC Method for Quantitative Analysis Voglibose in Pure and Pharmaceutical formulations. International Journal of Pharmaceutical, Chemical and Biological Sciences. 2013; 3(2) : 336-41.
8. Mallikarjuna RN. RP-HPLC method development and validation for estimation of Voglibose in bulk and tablet dosage forms. International Journal of Research in Pharmaceutical Sciences. 2010; 1(2) : 190-4.
9. Rajput M, Dahiyaet M, Kumari P, Kalra K, Aggarwal M and Khandal RK. Development and Validation for Determination of Voglibose in tablet Formulation Using LC-MS/MS. E Journal of Chemistry. 2011; 8(4), 1770- 83.
10. Shinde, C. C., S. Chopade, and S. S. Dhaneshwar. Development And Validation Of HPTLC Method For Estimation Of Voglibose In Pharmaceutical Dosage Forms. International Journal of Pharmacy and Pharmaceutical Sciences . 2015;7(5): 288-93.
11. G. Sowjanya, Ch. Sirisha, M. Krishna Prasad. New Validated UV Spectrophotometric Methods for the Determination of Sparfloxacin in Tablets. Research Journal of Pharmacy and Technology. 2020; 13(8):3587-3592.
12. Leela Madhuri P, Hemant Kumar T, Srinivasa Rao Y, Vara Prasada Rao K. UV Spectrophotometric Method for Estimation of Sacubitril in Synthetic Mixture. Asian Journal of Research in Chemistry. 2019; 12(1): 07-10.
13. ChaitanyaPSV, Hemant Kumar T., Srinivasa Rao Y.and Vara Prasada Rao K. Estimation of vortioxeine in bulk and pharmaceutical formulations by UV spectrophotometry. European Journal of Pharmaceutical and Medical Research . 2019,6(2), 389-392.
14. K. Vara Prasada Rao, M. Tanuja, Y. Srinivasa Rao and T. Hemant Kumar. Development And Validation Of Stability Indicating UV Spectrophotometric Method For The Estimation Of Zileuton In Bulk And Tablet Dosage Form. International Journal of Pharmacy. 2015; 5(2): 393-397.
15. Sasikala M, Mohan S, Gokilambal V, Mymoona S, Hari P. Validated UV-Visible Spectroscopic Analytical method development and stability studies on Oseltamivir. Research Journal of Pharmacy and Technology 2020; 13(9):4323-4328.
16. T. Hemant Kumar, K Manasa Reddy, D Rishika and R Prasanna Kumar. Estimation of Orlistat by UV Spectrophotometric method, International Journal of Pharmaceutical Sciences and Research. 2011, 2(9), 2469-2471.
17. Rajan V. Rele. UV Spectrophotometric estimation of Drotaverine hydrochloride by zero order and area under curve methods in bulk and Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2018; 11(12): 5576-5580.
18. K. Sonia, M. Nappinnai, P. Panneerselvam. Stability Indicating UV Method for Simultaneous Determination of Telmisartan and Amlodipine Besylate. Research Journal of Pharmacy and Technology. 2018; 11(11): 4825-4828.
19. ICH Harmonized Tripartite Guidelines, Validation of analytical procedure: Text and methodology'Q2(R1);2005.
20. ICH. Q2B Validation of analytical procedure: Methodology. International conference on harmonization, Geneva;1996.
21. ICH Harmonized Tripartite Guideline, Validation of analytical procedure: Methodology (Q2B); 1996.