Saish Naik, Celina Nazareth, Sanelly Pereira
Saish Naik, Celina Nazareth*, Sanelly Pereira
Department of Pharmaceutical Chemistry, P.E.S’s Rajaram and Tarabai Bandekar College of Pharmacy, Farmagudi, Goa, India- 403401.
Volume - 13,
Issue - 12,
Year - 2020
A novel, simple, precise, accurate and reproducible RP-HPLC method for cleaning validation and assay for simultaneous estimation of perindopril and amlodipine in tablet dosage form has been developed and validated. The chromatographic separation was performed on WATERS SHERISORB CN column (250mm×4.6mm,5µm) in an isocratic mode utilizing di-potassium hydrogen phosphate buffer (pH 6.5 with OPA): methanol: acetonitrile (70:20:10, v/v/v) as mobile phase, at a flow rate of 1.3 ml/min. Detection was carried out at 210 nm. The method was validated as per ICH guidelines for specificity, linearity, precision, accuracy, robustness, LOD and LOQ. The developed cleaning validation method was applied for the analysis of marketed formulation of the drugs. The retention times of perindopril and amlodipine were found to be 3.260 and 4.153 min respectively. The method was found to be specific as there was no swab interference. The Beer Lambert’s law was obeyed in the concentration range 0.5-10 µg/ml for both perindopril and amlodipine. The mean % recoveries at 100% level and % RSD were within acceptance limits for both perindopril and amlodipine. The limit of detection (LOD) and limit of quantitation (LOQ) for perindopril and amlodipine were found to be 0.2 µg/ml and 0.5 µg/ml respectively. The method was found to be robust. Assay of marketed tablet formulation gave assay results within acceptable levels.
Cite this article:
Saish Naik, Celina Nazareth, Sanelly Pereira. A Novel HPLC cleaning Validation and Assay method for the simultaneous estimation of Perindopril and Amlodipine. Research J. Pharm. and Tech. 2020; 13(12):5919-5923. doi: 10.5958/0974-360X.2020.01033.1
Saish Naik, Celina Nazareth, Sanelly Pereira. A Novel HPLC cleaning Validation and Assay method for the simultaneous estimation of Perindopril and Amlodipine. Research J. Pharm. and Tech. 2020; 13(12):5919-5923. doi: 10.5958/0974-360X.2020.01033.1 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-12-48
3. Tripathi KD. Essentials of Medical Pharmacology. Jaypee Brothers Medical Publishers (P) Ltd., New Delhi. 2013.
4. Zaazaa HE, Abbas SS, Essam HAM, El-bardicy MG. Validated Chromatographic Methods for Determination of Perindopril and Amlodipine in Pharmaceutical Formulation in the Presence of their Degradation Products. Journal of Chromatographic Science. 2013; 51:533–543.
5. Prajapati J, Patel A, Patel MB, Prajapati N, Prajapati R. Analytical method development and validation of Amlodipine besylate and Perindopril erbumine in combine dosage form by RP-HPLC. International Journal of Pharm Tech Research.2011; 3(2): 801–8.
6. Rajput PR, Bendale A, Luhar SV, Narkhede SB. Development and Validation of Stability Indicating RP-HPLC Method for Amlodipine Besylate and Perindopril Arginine in Synthetic Formulation. Journal of Pharmaceutical Science and Bioscientific Research.2016; 6(2271): 347–55.
7. Gumustas, Mehmet, Ozkan, Sibel A. A Validated Stability-Indicating RP-LC Method for the Simultaneous Determination of Amlodipine and Perindopril in Tablet Dosage Form and their Stress Degradation Behavior under ICH-Recommended Stress Conditions. Journal of AOAC International. July-August 2013; 96(4): 751-757.
8. Pattan SR, Patni AC, Mali RA, Patni CJ, Godge RK, Bhawar HS, Merekar AN, Marathe RP. Analytical Method Development and Validation of Perindopril Erbumine and Amlodipine Besylate in Bulk and Tablet Dosage Form by Hplc.2013; 50(5): 32-38.
9. Prajapati JP, Patel MB, Prajapati RJ, Prajapati NA. Simultaneous Determination of Perindopril Erbumine and Amlodipine Besylate by Absorption Factor Method. International Journal of Applied Biology and Pharmaceutical Technology. July-Sept -2011; 2(3): 230–233.
10. Raju VB, Rao AL. Simultaneous Estimation of Perindopril and Amlodipine In Combined Dosage Form By RP-HPLC Method. Int. J. Chem. Sci.2011; 9(3): 1290–1298.
11. Reddy YK, Harikrishna A, Tharun B, Kishore B, Saidhulu B, Rajitha B. A New RP-HPLC Method Development and Validation for the Amlodipine and Perindopril in Bulk and Tablet Dosage. International Journal of Medical and Pharma Research. 2016; 4(4): 20-26.
12. Nekkala K, J VSK, Ramachandran D, Ramanaiah G, Ganta S. Method Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Perindopril Erbumine and Amlodipine Besylate in Bulk and its Pharmaceutical Formulations. American Journal of Advanced Drug Delivery. 2014; 2(5): 672-685.
13. Haque SKM, Ratemi E. Validated Rp – Hplc Method for the Quantification of Ace Inhibitor Perindopril Arginine. European Journal of Pharmaceutical and Medical Research. 2016; 3(5): 171–175.
14. Dugga HHT, Peraman R, Nayakanti D. Stability-Indicating RP-HPLC Method for the Quantitative Analysis of Perindopril Erbumine in Tablet Dosage Form. Journal of Chromatographic Science, 2014; 52: 315–320.
15. Paczkowska M, Zalewski P, Garbacki P, Talaczyn A, Krause A. The Development and Validation of a Stability Indicating UHPLC DAD Method for Determination of Perindopril L Arginine in Bulk Substance and Pharmaceutical Dosage Form. Chromatographia. 2014; 77: 1497–1501.
16. Raju VB, Rao AL. Development and Validation of New Hplc Method for the Estimation of Perindopril in Tablet Dosage Foms. Rasayan Journal of Chemistry. 2011; 4(1): 113–116.
17. Sahoo S, Panda KP, Mishra SK, Sahoo S. Hplc Method Development for Simultaneous Estimation of Hydrochlorothiazide and Perindropril in Tablet Dosage Form. Asian Journal of Pharmaceutical and Clinical Research. 2012; 5(2): 136-138.
18. Tiwari R, Jain A, Maliwal D, Toppo E. Multicriteria Optimization Methodology in Development of Hplc Method for Simultaneous Estimation Of Indapamide and Perindopril in Bulk Drug and its Combine Dosage Form. Asian Journal of Pharmaceutical and Clinical Research. 2012; 5(3): 50-53.
19. Modi KD, Patel CN. Development and Validation of Spectrophotometric Method for Simultaneous Estimation of Perindopril and Indapamide in Combined Dosage Form by Absorbance Correction Method. 2010; 2(1): 411–416.