Aditya Mathur, Ravikumar Vejendla
Aditya Mathur1*, Ravikumar Vejendla2
1Assistant Professor, Dept. of Pharmaceutical Chemistry, B.M College of Pharmacy, Gurugram.
2Professor, Dept. of Pharmaceutical Analysis, St. Mary Pharmacy College, Hyderabad.
Volume - 13,
Issue - 2,
Year - 2023
The aim of this study is to develop and validate a method for the quantitative analysis of Rivastigmine tartarate capsules 1.5mg. An isocratic HPLC method using a reverse phase C-8 column and a mobile phase along with buffer (pH 3.0) was developed, optimized and validated. The analysis was carried out with a flow rate of 1.5 ml/min at 500C and was monitored at ?max - 220nm. Chromatogram of Rivastigmine tartarate was observed at 11min. The complete elution of Rivastigmine tartarate was achieved in 11.29 min at 220nm. This HPLC method showed good linearity, accuracy, selectivity, and other validation parameters. The recovery (accuracy) at all concentration levels was found to be more than 100% within the range of 102%. System suitability was determined by calculating the percent relative deviation (%RSD) for area five replicates injection of 120ppm in HPLC. All the peaks were resolved from the API with significantly different RT. Rivastigmine tartarate was subjected for stability indicating assay method which must be validated invariably calls for a forced degradation conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Rivastigmine tartarate was found to degrade significantly in base degradation condition and little in thermal, thermal humidity, photolytic, acid and oxidative stress degradation conditions.
Cite this article:
Aditya Mathur, Ravikumar Vejendla. Novel Method Development, Validation and Stability Indicating Assay Method for Rivastigmine Tartarate Capsule by HPLC. Asian Journal of Pharmaceutical Analysis. 2023; 13(2):79-8. doi: 10.52711/2231-5675.2023.00014
Aditya Mathur, Ravikumar Vejendla. Novel Method Development, Validation and Stability Indicating Assay Method for Rivastigmine Tartarate Capsule by HPLC. Asian Journal of Pharmaceutical Analysis. 2023; 13(2):79-8. doi: 10.52711/2231-5675.2023.00014 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-2-3
1. Khoury, Rita; Rajamanickam, Jayashree; Grossberg, George T. (2018-01-08). An update on the safety of current therapies for Alzheimer's disease: focus on rivastigmine. Therapeutic Advances in Drug Safety. SAGE Publications. 9(3): 171–178.
2. Winblad, B.; Grossberg, G.; Frölich, L.; Farlow, M.; Zechner, S.; Nagel, J.; Lane, R. (2007). IDEAL: A 6-month, double-blind, placebo-controlled study of the first skin patch for Alzheimer disease. Neurology. 69 (4 Suppl 1): S14–S22.
3. Inglis, F. (2002). The tolerability and safety of cholinesterase inhibitors in the treatment of dementia. International Journal of Clinical Practice. Supplement (127): 45–63.
4. ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (revision2), International Conference on Harmonization.
5. Ngwa George, Forced Degradation as an Integral Part of HPLC Stability-Indicating Method Development, Drug Delivery Technology (2010).
6. Singh S, Bakshi M. Guidance on conduct of stress tests to determine inherent stability of drugs. Phrama Tech 2000; 24: 1-14.
7. ICH Guidance for Industry, Q1B: Photo stability testing of New Drug Substances and Product, International Conference on Harmonization, 1996.
8. L. Satyanarayana, S.V. Naidu, M. Narasimha Rao, C. Ayyanna, Alok Kumar. The Estimation of Raltigravir in Tablet dosage form by RP-HPLC. Asian J. Pharm. Ana. 1(3): July-Sept. 2011; Page 56-58.
9. A. Thenmozhi, D. Sridharan, S. Veeramani, M. Palanivelu. An RP-HPLC Method for the estimation of Dexibuprofen in Pharmaceutical Tablet Dosage Form. Asian J. Pharm. Ana. 1(4): Oct. - Dec. 2011; Page 98-99.
10. Sharmin Reza Chowdhury, Mahfuza Maleque, Mahbubul Hoque Shihan. Development and Validation of a Simple RP-HPLC Method for Determination of Caffeine in Pharmaceutical Dosage Forms. Asian J. Pharm. Ana. 2(1): Jan.-Mar. 2012; Page 01-04.
11. Shiv Kumar Gupta, Babita Kumar, Pramod Kumar Sharma. Development and validation of a RP-HPLC method for estimation of Thalidomide in solid dosage form. Asian J. Pharm. Ana. 3(1): Jan.-Mar. 2013; Page 17-19.
12. D. Narmada, P.V. Murali Krishna, Shaik Mohammad Yusuf, B. Ranganayakulu, K. Uday Praveen, P. Raja Abhilash. RP-HPLC method development and validation for estimation of Glibenclamide in tablet dosage form. Asian J. Pharm. Ana. 4(3): July-Sept 2014; Page 125-128.
13. Govinda Rao Kamala, Sowjanya Vadrevu, Malipeddi Haripriya. Method Development and Validation for Simultaneous Estimation of Omeprazole and Domperidone by RP-HPLC. Asian J. Pharm. Ana. 5(4): 2015; 195-205.
14. Sushil D. Patil, Sunil V. Amurutkar, C.D. Upasani. Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin. Asian J. Pharm. Ana. 2016; 6(4): 201-206.
15. Sunita N Surse Sushil D Patil Kunal R Deshmukh Sanjay J Kshirsagar. Development and Validation of Analytical Method by RP-HPLC and Forced Degradation Studies of Tioconazole Drug. Asian J. Pharm. Ana. 2019; 9(4):229-231.
16. Bhavana. G, Indira Priyadarshini. G, Apuroopa. Method Development and Validation of Stability Indicating RP-HPLC for the Estimation of Felodipine PR Tablets. Asian J. Pharm. Ana. 2020; 10(4):207-212.
17. Mohan Goud V, Tharun Goud G. Stability indicating high performance liquid chromatography method development and validation for simultaneous estimation of Glecaprevir and Pibrentasvir in bulk and pharmaceutical dosage form. Asian J. Pharm. Ana. 2020; 10(3): 141-146.