A Nanodrop Spectrophotometric Method and Stability Indicating for Determination of Amlodipine Besylate in Pharmaceutical Formulations of Kurdistan of Iraq
A nanodrop spectrophotometric method was developed and validated for determination of amlodipine besylate (AB) in bulk and tablet dosage form. The maximum absorption of amlodipine was shown at 357 nm using acetonitrile as a solvent. The developed method was found to be linear (R2 = 0.9990) within the concentration range of 2-10 µg/mL. The precision study showed acceptable values of RSD% (less than 1%). LOD and LOQ values were found to be 0.34 and 1.14 µg/mL, respectively. Accuracy study showed good recovery 99% Awalodipine and 98.88% Amloneer, in locally commercial tablets. The present method was applied successfully for stability indicating study of AB in Awalodipine and Amloneer products manufactured in (Erbil and sulaymaniyah, respectively)/ Kurdistan of Iraq. The stability-indicating study was investigated under acidic, basic, oxidative, photolytic, and thermal conditions. The results of both products showed that AB is unstable in acidic, alkaline, and oxidative conditions under heating at 60℃ up to 5 hrs. While under photolytic and thermal conditions, the degradation percentage was less than 15% indicating to the stability of AB in both Awalodipine and Amloneer tablets according to International Conference on Harmonization (ICH) guideline of drugs. It can be concluded that the main factor that affects the degradation of AB is the passage of time.
Aram, V., George, L., Henry, R., William, C., Lee, A., Joseph, L., Daniel, W., Barry, J., Suzanne, O., Jackson, T., & Edward J. (2003). Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, Hypertension, 42(6), pp. 1206–1252. Doi: 10.1161/01.HYP.0000107251.49515.c2.
Attimarad M., Venugopla K., Bandar E., Nagaraja S., And Anroop Ba.(2019) Development of UV Spectrophotometric Procedures for Determination of Amlodipine and Celecoxib in Formulation: Use of Scaling Factor to Improve the Sensitivity, Journal of Spectroscopy, 2019. Doi: 10.1155/2019/8202160.
Bernard, S., Mathew, M., & Senthilkumar, K. L. (2011). Spectrophotometric method of estimation of Amlodipine besylate using hydrotropic solubilization, Journal of Applied Pharmaceutical Science, 1(9), pp. 177–180.
Chakraborty, S., Sharmin S., Rony S., Ahmad, S., & Sohrab Md. (2018). Stability-indicating UV/vis spectrophotometric method for diazepam, development and validation, Indian Journal of Pharmaceutical Sciences, 80(2), pp. 366–373. Doi: 10.4172/pharmaceutical-sciences.1000366.
Chatuevedi, k., & Chaturved, S. (2004) stability indicating assay method for Amlodipine tablets.
Chitlange, S., Imran, M., & Sakarkar, D. (2008). RP-HPLC method for simultaneous estimation of Amlodipine and metoprolol in tablet formulation, Asian Journal of Pharmaceutics, 018(December), pp. 232–234.
Ferenczi-Fodor, K. Et al. (2001) ‘Validation and quality assurance of planar chromatographic procedures in pharmaceutical analysis’, Journal of AOAC International, 84(4), pp. 1265–1276. Doi: 10.1093/jaoac/84.4.1265.
Hemmateenejad, B. (2009). A Kinetic Spectrophotometric Method for Determination of Amlodipine and Nifedipine in pharmaceutical preparations, 25(2), pp. 31–38.
Khatib O., & Mohamed G. (2005). clinical duidlines for the managment of hypertension.
Koumudi Annamaneni. (2012). method development and validation of simultaneous estimation of telmisartan and hydrochlorothiazide in pharmaceutical dosage forms by RP-HPLC.
Kumar, M., Mohit J., & Shailendra B. (2019). Simultaneous Estimation of Amlodipine Besylate and Ramipril in Tablets Dosage Form by UV Spectrophotometric Method, Journal of Pharmaceutical Sciencees and Research, 11(2), pp. 667–670.
Kushwaha, D., Sunil D., Sarita K., & Hemant K.(2019). Novel UV Spectrophotometer Methods for Quantitative Estimation of Concensi (Amlodipine 10mg and Celecoxib 200mg) Using Hydrotropic Solubilizing Agents, Journal of Drug Delivery and Therapeutics, 9(4-A), pp. 651–655.
Mahmoud, A. M., Abdel-Wadood, H. M. & Mohamed, N. A. (2012) Kinetic spectrophotometric method for determination of mlodipine besylate in its pharmaceutical tablets, Journal of Pharmaceutical Analysis. Elsevier, 2(5), pp. 334–341. Doi: 10.1016/j.jpha.2012.03.002.
Mathew, M., Sheyni, B., Senthil k., & Girija A. (2014). development and validation of a HPTLC method for the simultaneous estimation of Atorvastatin calcium and Amlodipine besylate as the bulk drugs and in the tablet dosage form, Asian journal of pharmaceutical and Health Sciences, pp. 986–991.
Meyyanathan, S. N., & Suresh, B. (2005). HPTLC method for the simultaneous determination of amlodipine and benazepril in their formulations, Journal of Chromatographic Science, 43(2), pp. 73–75. Doi: 10.1093/chromsci/43.2.73.
Mohamed, A. M. (2019). Simultaneous Determination of Amlodipine Besylate, Valsartan, and Its Related Substances in Their Film-Coated Tablets Dosage form by RP-HPLC Method, Advanced Journal of Chemistry-Section A, 2(4), pp. 337–346. Doi: 10.33945/sami/ajca.2019.4.7.
Nagamani, P., Manjunath, SY., Hemant Kumar, T. (2020). Development and validation of RP-HPLC method for estimation of amlodipine besylate and losartan potassium in multidrug marketed formulation, International Journal of Pharmacy and Technology, 5(1), pp. 5188–5198.
Prajakta, G., & Ravindra, B. Saudagar. (2018). Review on analytical method development and validation by RP-HPLC.
Pradeep, M., Kamal, S., & Alka, G. (2009). Spectrophotometric methods for simultaneous estimation of nebivolol hydrochloride and amlodipine besylate in tablets, International Journal of chemtech Research, 1(4), pp. 991–995.
Priyanka, R., Sachin, U., & Burade KB. (2009). Simultaneous UV Spectrophotometric methods for estimation of losartan potassium and amlodipine besylate in tablet dosage form, Research Journal of Pharmaceutical, Biological and Chemical Sciences, 3(3), pp. 397–404.
Rima, N. Shah., Deesha, B. Gandhi., & Mehul M. Patel. (2013). Simultaneous estimation and forced degradation studies of amlodipine besylate and indapamide in tablet dosage form by RP-HPLC method, Der Pharma Chemica, 5(6), pp. 347–352.
Sekhar, K., Abbas, S., Chandra, M., Hamana, N., Kalyan, P., Rajesh, J., & Varun, B. (2020). Validation methods of amlodipine drug with comparative study of standard and sample by using UV- spectroscopy, 18, pp. 100–104.
Sharma, M., Kothari, C., Sherikar, O., & Mehta, P. (2014). Concurrent estimation of amlodipine besylate, hydrochlorothiazide and valsartan by RP-HPLC, HPTLC and UV-spectrophotometry, Journal of Chromatographic Science, 52(1), pp. 27–35. Doi: 10.1093/chromsci/bms200.
Topa, K., Pankaj, S., Paras, M. & Tej, P. (2011). Nanodrop spectrophotometric method development and validation for estimation of ranolazine in their bulk, international journal pharmaceutical science researcher, 2(4), pp. 985–998.
Copyright (c) 2021 Faroq O. Qasim, Nidhal M. Sh. Mohammed
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License [CC BY-NC-SA 4.0] that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work, with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online.