Parthasarathi Thoddi, Girendra Kumar Gautam CH, Narasimha Raju BH
Parthasarathi Thoddi1*, Girendra Kumar Gautam CH2, Narasimha Raju BH3
1Bhagwant University Ajmer, India.
2Shriram College of Pharmacy, Muzaffarnagar, India.
3Vagdevi College of Pharmacy, Gurjala, India.
Volume - 15,
Issue - 1,
Year - 2022
A specific, precise, rapid and reliable stability indicating UPLC method has been developed and validated for simultaneous separation and estimation of Epalrestat and Pregabalin in bulk drugs and marketed formulations. Chromatographic separation was achieved on a agilent Zorbax SB C18 (2.1 x 100mm, 1.8µm) column using isocratic mode of elution with 0.1% Formic acid and Acetonitrile in the ratio 60:40 v/v at a flow rate of 1.0 mL/min and analytes were monitored at 226nm. The retention times of Epalrestat and Pregabalin were about 0.97 and 1.27 minutes respectively. The developed method was validated for specificity, linearity, precision, accuracy, ruggedness and stress degradation studies were established. The results of specificity and stability studies indicate that there was no interference of diluent, excipients, and degradation products at respective retention times of analytes. The detector response was linear in the range of 10-150% level with respect to test concentration of Epalrestat and Pregabalin. Correlation coefficient (R2) was found not less than 0.999 for both analytes. The percentage assay of Epalrestat and Pregabalin were about 100.99% and 100.77% respectively. Hence, the developed method was rapid, specific, accurate and economical, and it can be used for routine analysis of these drugs in bulk and marketed formulations.
Cite this article:
Parthasarathi Thoddi, Girendra Kumar Gautam CH, Narasimha Raju BH. A Stability-Indicating UPLC Method for Simultaneous Quantification of Epalrestat and Pregabalin in Bulk and Marketed Formulations. Research Journal of Pharmacy and Technology. 2022; 15(1):206-2. doi: 10.52711/0974-360X.2022.00034
Parthasarathi Thoddi, Girendra Kumar Gautam CH, Narasimha Raju BH. A Stability-Indicating UPLC Method for Simultaneous Quantification of Epalrestat and Pregabalin in Bulk and Marketed Formulations. Research Journal of Pharmacy and Technology. 2022; 15(1):206-2. doi: 10.52711/0974-360X.2022.00034 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-1-34
1. Sharma SR, Nalini Sharma, Epalrestat an aldose reductase inhibitor in diabetic neuropathy: An Indian perspective. Annals of Indian academy of Neurology. 2008; 11: 231-235.
5. Ramya Shruthi K, Gopala Rao P, et al Efficacy of Epalrestat and Pregabalin in Patients with Diabetic Peripheral Neuropathy, 2018, 5(1):413-416
6. Sravanthi T, Madhavi N. Stability indicating UPLC method for simultaneous estimation of Epalrestat and Pregabalin in tablet dosage form. Research J. Pharm. and Tech. 2019; 12(2): 489-494.
7. Banerjee, Janmajoy, Padmalatha H, Rahul, Chanda, Ranabir Method development and validation for the simultaneous estimation of Eplarestat and Pragabalin in Bulk and Pharmaceutical Formulation by using RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2018; 8(3):174-180
8. Sivagami B, Kavya Lalitha S, Pavan Kumar V, Sireesha R, et al Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of Epalrestat and Pregabalin in tablet dosage forms. International research journal of pharmacy. 2018; 9(5): 45-52
9. Swapna Goday, Abdul Rahaman Sk, Prameela Rani A, Development of a new stability indicating RP-HPLC method for simultaneous estimation of Epalrestat and Pregabalin and its validation as per international conference on harmonization guidelines. Asian J Pharm Clin Res. 2018; 11(5): 319-324.
10. Madhu Harika B, Rajendra Prasad Y, Development and Validation of Stability Indicating RP-HPLC method for simultaneous estimation of Epalrestat and Pregabalin in bulk and tablet dosage form. Int J Pharm. 2017; 7(2): 157-164.
11. Prasanthi D, Prasada Rao Ch. M.M, Dhachinamoorthi D, Analytical method development and validation of RP-HPLC for estimation of Pregabalin and Epalrestat in pure and pharmaceutical dosage form, World Journal of Pharmaceutical and Medical Research. 2019; 5(9): 223-232.
12. Atul A, Shirkhedkar, Chetan S, Nankar, Sanjay J, Surana, Quantitative determination of Epalrestat by RP-HPLC method. Eurasian J Anal Chem. 2012; 7(1): 49-55.
13. Jampala Balaji, Bandi Ramachandra, Naidu NVS. Analytical RP-HPLC method for development and validation of Pregabalin in bulk and the determination of Pregabalin in capsule dosage form. International Journal of Innovative Research in Science, Engineering and Technology. 2014; 3(4): 11094-11098.
14. Prashant Pingale, Tanmay Singasane, Development and validation of HPLC method for the determination of pregabalin in bulk and in pharmaceutical formulations, Research Journal of Pharmacy and Technology.
1. 2012: 5(6): 829-833.
15. Kasawar GB and Farooqui MN. Development and Validation of HPLC Method for the Determination of Pregabalin in Capsules. Indian Journal of Pharmaceutical Sciences. 2010; 72(4): 517-519.
16. Vaishali, Vikas Singh, Rajnish Kumar Singh, Ramesh Kumar Gupta, Sudhansu Ranjan Swain and Jagannath Sahoo. Development and validation of RP-HPLC method for the Assay of Pregabalin capsule. World Journal of Pharmaceutical Sciences. 2013; 3(1): 703-711.
17. Naresh Chandra Reddy M and Chandra Sekhar K. RP-HPLC Determination of Related substances of Pregabalin in bulk and pharmaceutical dosage form. International Journal of Chemical and Pharmaceutical Sciences. 2012; 3(2): 40-46.
18. Sneha P and Prathima Srinivas. Stability indicating assay method development and validation of pregabalin in pharmaceutical dosage forms by RP-HPLC. Indo American J of Pharm Sci. 2015; 2(6): 1038-1047.
19. Sowjanya P. RP HPLC Method Development of Pregabalin in Bulk, Dosage Form and Validation Parameters. Journal of Hospital and Clinical Pharmacy. 2016; 2(4): 61-75.
20. Anil Mohan J, Rajkumar B, Bhavya T and Ashok Kumar A. RP-HPLC method Development and validation for the simultaneous quantitative estimation of pregabalin, mecobalamin and alpha lipoic acid in capsules. Internationals Journal of Pharmacy and Pharmaceutical Sciences. 2014; 6(1): 270-277.
21. Akshay Tripathi, R.P. S Rathor, P.R. Kamble, Girish Vyas. Reverse Phase HPLC Method for Estimation of Acelofenac and Pregabalin in Combined Dosage Form. International Journal of Pharmamedix India. 2014; 2(3): 764-780.
22. Ashutosh Kumar S, Manidipa Debnath, Seshagiri Rao JVLN and Gowri Sankar D. Stability Indicating Analytical Method Development and Validation for Simultaneous Estimation of Pregabalin, Mecobalamin and Alpha Lipoic Acid in Bulk as well as in Pharmaceutical Dosage Form by using RP-HPLC. Research Journal of Pharmacy and Technology. 2014; 7(9): 1004-1013.
23. Eswara Rao Bammidi, Vaikuntarao Lakinani, Subrahmanyam Lanka, Pavitra Paila and Mallikarjun Rao Duvvada. Development, Validation and Degradation Studies of RP-HPLC Method for the Determination of Pregabalin in Oral Suspension Powder. International Journal of Medicine and Pharmaceutical Research. 2015; 3(5): 1151-1156.