Volume : 09, Issue : 06, June – 2022
Title:
35.ANALYTICAL METHOD DEVELOPMENT AND VALIDATION USING RP – HPLC FOR SIMULTANEOUS ESTIMATION OF ENALAPRIL AND LOSARTAN IN BULK SAMPLES AND TABLET DOSAGE FORMS
Authors :
Azmat Unnisa *, Y. Rajendra, Dr.Khaja Zeeyauddin
Abstract :
Objective: A simple, Accurate, precise method was developed for the simultaneous estimation of the Enalapril and Losartan in pharmaceutical dosage form.
Methods: Chromatogram was run through Phenomene x C 18 column (150×4.6mm, 5µm). Mobile phase containing Buffer: ACN:Methanol (30:5:65) pH 3.5 was pumped through column at a flow rate of 1.2 ml/min. Buffer used at pH 3.5. Temperature was maintained at Ambient. Optimized wavelength for Enalapril and Losartan was 249 nm.
Results: Retention time of Enalapril and Losartan were found to be 5.04 min and 9.71 min. The % purity of Enalapril and Losartan was found to be 100.03 % and 99.75 % respectively. The system suitability parameters for Enalapril and Losartan such as theoretical plates and tailing factor were found to be 4836,0.97 and 3568, 1.42. the resolution was found to be 8.0. The linearity study for Enalapril and Losartan was found in concentration range of 5μg-15 μg and 200 μg-600 μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100.19 % and 100.84 %, %RSD for repeatability was 0.75 and 0.36 %. The precision study was precise, robust and repeatable. LOD value was 0.08 and 0.25, and LOQ value was 1.08 and 0.35 respectively
Conclusion: The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Enalapril and Losartan in pharmaceutical dosage form.
Keywords: Enalapril, Losartan, RP‐HPLC, Simultaneous estimation.
Cite This Article:
Please cite this article in press Azmat Unnisa et al, Analytical Method Development and Validation using RP – HPLC for Simultaneous Estimation of Enalapril and Losartan in bulk samples and tablet dosage forms., Indo Am. J. P. Sci, 2022; 09(6).,
Number of Downloads : 10
References:
1. Davies RO, Gomez HJ, Irvin JD, Walker JF: An overview of the clinical pharmacology of enalapril. Br J Clin Pharmacol. 1984;18 Suppl 2:215S-229S. (PubMed ID 6099737)
2. Sica DA, Gehr TW, Ghosh S: Clinical pharmacokinetics of Losartan. Clin Pharmacokinet. 2005;44(8):797-814. [Article]
3. Zhou SF, Zhou ZW, Yang LP, Cai JP: Substrates, inducers, inhibitors and structure-activity relationships of human Cytochrome P450 2C9 and implications in drug development. Curr Med Chem. 2009;16(27):3480-675. Epub 2009 Sep 1.
4. Chaudhari, Bharat. (2012). Headway and Validation of RP-HPLC Method for Simultaneous Estimation of Enalapril Maleate and Amlodipine Besylate in Combined Dosage structure. Journal of Applied Pharmaceutical Science. 2. 054-057, 10.7324.
5. Mohammed E. A. Hammouda*, Mohamed A. Abu El-Enin, Dina T. El-Sherbiny, Dalia R. El-Wasseef and Saadia M. El-Ashry, Simultaneous Determination of Enalapril and Hydrochlorothiazide in Pharmaceutical Preparations Using Microemulsion Liquid Chromatography. Journal of Chromatographic Science 2015;53:90-96
6. Halder, Dhiman and Dan, Shubhasis and Pal, Murari and Biswas, Easha and Chatterjee, Nilendra and Sarkar, Pradipta and Halder, Umesh and Pal, Tapan. (2017). LC-MS/MS analyze for quantitation of enalapril and enalaprilat in plasma for bioequivalence study in Indian subjects. Future Science O A. (2017) FSO165. 10.4155
7. Kamini Sethy , Janhavi R Rao , K Raja Rajeswari and KEV Nagoji, Validated HPTLC methodology for coordinated appraisal of metoprolol succinate and ramipril in mass medicine and publicized arrangement, Clin Med Rep, 2019, 2: 1-4
8. Patel Meghna P, Nehal Shah2 , Shah Vivek, Satyendra Deka, Saralai M.G, Review on Simultaneous Determination of Antihypertensive Analytes in Pharmaceutical Dosage Form by Different Analytical Methods. 2012 2(2) 09-15.