Development and Validation of RP-HPLC method for the simultaneous determination of Diltiazem HCl and Enalapril Maleate
Keywords:
RP-HPLC, Diltiazem HCl, Enalapril Maleate, simultaneous estimationAbstract
A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Diltiazem HCl and Enalapril Maleate in pharmaceutical dosage form. Chromatographic separation of Diltiazem HCl and Enalapril Maleate was achieved on Waters Alliance-e2695 by using Inertsil ODS (250x 4.6mm, 5µ) column and the mobile phase containing Acetonitrile: 0.1% Formic acid in the ratio of 40:60% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 272nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Diltiazem HCl and Enalapril Maleate were NLT 2000 and should not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Diltiazem HCl and Enalapril Maleate study of its stability.
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Shubhangi R. Mali, Karishma R. Gulave, et al., Development and validation of RP-HPLC method for the simultaneous estimation of Enalapril Maleate and Diltiazem Hydrochloride in combined dosage form: International Journal of Novel Research and Development, 2023; 8(7):1-6.
Sidhdhapara MJ, Biraju P & Ashok P. Development And Validation Of Rp-Hplc Method For Simultaneous Estimation Of Cilnidipine And Olmesartan Medoxomil In Their Combined Tablet Dosage Form International Journal of Pharmacy and Biological Sciences. 2014; 4(1): 157-160. 6.
Amit SM, Manjusha ND, Sanjay DS. Developement and validation of analytical method for simultaneous Estimation of cilnidipine and olmesartan medoxomil in bulk and tablet Dosage form by rp-hplc. International Journal of Pharmacy and Pharmaceutical Sciences. 2014; 6(7): 508-511.
Ghelani NC, Dadhania K, Faldu S. Analytical Method Development and Validation for Simultaneous Estimation of Olmesartan Medoxomil and Cilnidipine in their Combined Pharmaceutical Dosage form by RP-HPLC Method. PharmaTutor. 2014; 2(7); 142-148.
Heyden, Y. Vander; S.W. Smith; et al. "Guidance for robustness/ruggedness tests in method validation". Journal of Pharmaceutical and Biomedical Analysis. Elsevier. 2001; 24 (5–6): 723–753.
Purnima D. Hamrapurkar, Kamalesh K. Gadapayale Optimization and Validation of RP-HPLC Stability Indicating method for determination of olmesartan medoxomil and Its degraded product. International Journal of Applied Science and Engineering. 2013;11( 2):137-4713.
Mohammed Safhi M, Nagaraj Manohara Y. Development and validation of a rapid stability indicating chromatographic determination of cilnidipine in bulk and dosage form. Research Journal of Pharmacy and Technology. 2013;6(3):296-99.
Manzoor Ahmed, Rashmi D.R, Satishkumar Shetty A, Anil Kumar S.M, Ravi M.C, Kuppast I.J. Rp-hplc method development and validation for simultaneous estimation of cilnidipine and olmesartan medoxomil in combined tablet dosage form. World journal of pharmacy and pharmaceutical sciences. 2015; 4(1): 785- 795.
Anuradha. V, Rashmita. G, Rameezuddin. MD, Gayatri. P, Ramesh. TDevelopment and validation of sensitive spectrophotometric method for estimation of olmesartan medoxomil in pharmaceutical dosage form. International Journal of Biological Pharmaceutical Research. 2012;3(6):796-9910.
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