UV-SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SAXAGLIPTIN IN API AND PHARMACEUTICAL DOSAGE FORM
DOI:
https://doi.org/10.22159/ijcpr.2020v12i5.39768Keywords:
Saxagliptin, UV spectrophotometer, Method validation, MethanolAbstract
Objective: A new sensitive, economical, simple, rapid UV spectrophotometric method has been developed for the estimation of Saxagliptin in API and pharmaceutical formulation.
Methods: Calibration curve method was used for the estimation of Saxagliptin in API and pharmaceutical formulation.
Results: The method was validated for linearity, range, accuracy, precision, robustness, LOD, LOQ. Linearity was found in the range of 10-60µg/ml. Accuracy was performed by using a recovery study. The amount of drug recovered was found to be in the range of 99.01-100.1%. All the parameters were validated as per the ICH guidelines.
Conclusion: This method is suitable forused routine analysis of present Saxagliptin in API and Pharmaceutical dosage form.
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References
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10. Gandla Kumar Swamy, S Shruthi, M Rajkumar. A new stability indicating RP-HPLC method for simultaneous determination of saxagliptin and dapagliflozin bulk and combined tablet dosage forms. Asian J Pharm Anal Med Chem 2017;5:113-21.
11. B Reddy Padmaja, B Sivagami, R Chandrasekar. A highly validated RP-HPLC method development for simultaneous estimation of dapagliflozin and saxagliptin in tablet dosage forms. Int J Pharm Sci Drug Res 2018;10:372-8.
12. Pawaneet J Chhabda, M Balaji, Srinivasarao V. Development and validation of simple stability indicating RP-HPLC method for analysis of saxagliptin and its forced degradation impurities in bulk drug and pharmaceutical dosage form. Int J Res Dev Pharm Life Sci 2014;3;993-1003.
13. Sanjeev V Deshpande, Madhumita A Roy, Shubhangi C Daswadkar. Development and validation of UV-spectrophotometric method for estimation of saxagliptin in bulk and pharmaceutical dosage form. IJPDA 2016;4:30-4.
14. Raghvendra Singh Bhadauria, Vikas Agarwal. Development and validation of UV spectroscopic method for simultaneous estimation of dapagliflozin and saxagliptin in marketed formulation. JDDT 2019;9:1160-4.
15. Raveendra BG, Kumar RA, Shaheen SD. A novel stability-indicating method for the simultaneous estimation of saxagliptin and dapagliflozin in rat serum by using UV spectroscopy. PAA 2018;9:1-5.
16. Pravin Cholke, Mrunal Shirsath, Yogita Temak. Development and validation of UV-Visible spectroscopy method for simultaneous estimation of saxagliptin and metformin hydrochloride in tablet dosage form. IJRPPS 2018;3:31-4.
17. Mohd Zameeruddin, Sandhya S Bundel, Vishvanath B Bharkad. Development and validation of UV spectroscopy method for simultaneous estimation of dapagliflozin and saxagliptin in synthetic mixture. IJPAR 2019;8:59-66.
2. https://www.Drugbank.ca.DB06335. [Last accessed on 10 May 2020]
3. International Conference on Harmonization ICH (R1), validation of analytical procedure: text and methodology; 2005.
4. R Aswini, MM Eswarudu, P Srinivas Babu, A review on analytical methods for estimation of dapagliflozin and saxagliptin in bulk and in pharmaceutical dosage form. Int J Res Pharm Chem 2018;8:460-8.
5. Asim M Sutar, Laxman M Prajapti, Amit K Joshi. Estimation of saxagliptin hydrochloride and dapagliflozin propendiol monohydrate in combined dosage form. JIAPS 2018;3:1-7.
6. Narendra Nyola, Govinda Samy Jeyabalan. Development and validation of uv-vis spectroscopy method for simultaneous estimation of saxagliptin hydrochloride and metformin hydrochloride in active pharmaceutical ingrident. JPER 2012;3:19-23.
7. Pranali S Sisode, Hasumati A Raj, Vineet C Jain. Simultaneous determination of saxagliptin hydrochloride and glibenclamide in synthetics mixture using spectrophotometric technique. AJOPA 2016;6:77.
8. Vijaya U Barge, Fainaz M Chaudhari. Development and validation of analytical method for simultaneous estimation of saxagliptin and metformin HCL by using RP-HPLC method. Int Res J Pharm 2018;9:142-7.
9. Phani RSCH, Prasad KRS, Useni Reddy Mallu. A study of new method development, validation and forced degradation for simultaneous analysis of dapagliflozin and saxagliptin in pharmaceutical dosage form by HPLC method. DPC 2017;9:96-103.
10. Gandla Kumar Swamy, S Shruthi, M Rajkumar. A new stability indicating RP-HPLC method for simultaneous determination of saxagliptin and dapagliflozin bulk and combined tablet dosage forms. Asian J Pharm Anal Med Chem 2017;5:113-21.
11. B Reddy Padmaja, B Sivagami, R Chandrasekar. A highly validated RP-HPLC method development for simultaneous estimation of dapagliflozin and saxagliptin in tablet dosage forms. Int J Pharm Sci Drug Res 2018;10:372-8.
12. Pawaneet J Chhabda, M Balaji, Srinivasarao V. Development and validation of simple stability indicating RP-HPLC method for analysis of saxagliptin and its forced degradation impurities in bulk drug and pharmaceutical dosage form. Int J Res Dev Pharm Life Sci 2014;3;993-1003.
13. Sanjeev V Deshpande, Madhumita A Roy, Shubhangi C Daswadkar. Development and validation of UV-spectrophotometric method for estimation of saxagliptin in bulk and pharmaceutical dosage form. IJPDA 2016;4:30-4.
14. Raghvendra Singh Bhadauria, Vikas Agarwal. Development and validation of UV spectroscopic method for simultaneous estimation of dapagliflozin and saxagliptin in marketed formulation. JDDT 2019;9:1160-4.
15. Raveendra BG, Kumar RA, Shaheen SD. A novel stability-indicating method for the simultaneous estimation of saxagliptin and dapagliflozin in rat serum by using UV spectroscopy. PAA 2018;9:1-5.
16. Pravin Cholke, Mrunal Shirsath, Yogita Temak. Development and validation of UV-Visible spectroscopy method for simultaneous estimation of saxagliptin and metformin hydrochloride in tablet dosage form. IJRPPS 2018;3:31-4.
17. Mohd Zameeruddin, Sandhya S Bundel, Vishvanath B Bharkad. Development and validation of UV spectroscopy method for simultaneous estimation of dapagliflozin and saxagliptin in synthetic mixture. IJPAR 2019;8:59-66.
Published
15-09-2020
How to Cite
SHINDE, B. S., M. S. KALSHETTI, and A. P. KOKANE. “UV-SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SAXAGLIPTIN IN API AND PHARMACEUTICAL DOSAGE FORM”. International Journal of Current Pharmaceutical Research, vol. 12, no. 5, Sept. 2020, pp. 63-66, doi:10.22159/ijcpr.2020v12i5.39768.
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