SIMULTANEOUS ESTIMATION OF AZILSARTAN AND CILNIDIPINE IN BULK BY RP-HPLC AND ASSESSMENT OF ITS APPLICABILITY IN MARKETED TABLET DOSAGE FORM

Authors

  • SWATI M. ANDHALE Y. B. Chavan College of Pharmacy, Rauza Bag, Aurangabad 431001, MS, India
  • ANNA PRATIMA G. NIKALJE Wilson College, Chowpatty Seaface Road, Mumbai 400007, MS, India

DOI:

https://doi.org/10.22159/ijap.2022v14i1.42208

Keywords:

Azilsartan, Cilnidipine, RP-HPLC, Linearity and Range, Precision,

Abstract

Objective: This study aims to build up the RP-HPLC process for Azilsartan and Cilnidipine and authenticate the RP-HPLC process according to ICH validation code Q2R1.

Methods: System suitability testing was performed to discover the qualifying criterion of the method by injecting the identical standard solution of Azilsartan 40μg/mL and Cilnidipine 10μg/mL in mixture/combination in subsequent optimized chromatographic conditions and the chromatogram was recorded.  Moreover, the planned method was validated as per ICH guideline Q2R1 for the following parameters: linearity and range, precision, accuracy, robustness, and determined % recovery.

Results: The outcomes of %RSD for retention time and peak area were found to be 0.65 and 1.32 for Azilsartan and 0.85 and 1.90 for Cilnidipine. The correlation coefficient, y-intercept, slope of the regression line were 0.9996, -1127.1, 3313.9, and 0.9993, 1460.2, 2876.4 for Azilsartan and Cilnidipine, respectively. Moreover, the range of this method was observed to be 40-240μg/mL and 10-60 μg/mL for Azilsartan and Cilnidipine, standard concentrations respectively. The % RSD achieved for precision (repeatability) was observed in the range of 1.57 to 2.43 for Azilsartan and 0.70 to 1.88 for Cilnidipine. The % accuracy was found in the range of 96.96 to 101.92% w/w for Azilsartan and 99.19 to101.96%w/w for Cilnidipine. The percent recovery values achieved for Azilsartan were in the range of 99.87 to 106.39% w/w and for Cilnidipine in the range of 94.51 to 105.96% w/w.

Conclusion: The author concludes that the simultaneous estimation of Azilsartan and Cilnidipine with predefined objectives was successfully achieved. Moreover, the method was found to be steadfast for the quantification of Azilsartan and Cilnidipine in marketed tablet dosage forms.

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References

Sanjay Kumar D and Harish Kumar DR, Importance of RP-HPLC in analytical method development: A review, IJPSR 2012; 3(12):4626-4633.

Ravi Sankar P, Sai Snehalatha K, Shaik TF, Srinivasa Babu P, Applications of HPLC in pharmaceutical analysis 2019; 59(1):117-124.

Sohni SK, Kumar R, Akhtar M, Ranjan C, Chawla G, Development and validation of RP -HPLC method for simultaneous estimation of Azilsartan medoximil and Chlorthalidone in bulk form and formulation using quality by design 2016; 8(2):266-272.

Baker WL, White WB. Azilsartan medoxomil : a new angiotensin II receptor antagonist for the treatment of hypertension. Ann Pharmacother 2011; 45:1506-15.

White WB, Weber MA, Sica D, Bakris GL, Perez A, Cao C, Kupfer S. Effects of the angiotensin receptor blocker Azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Hypertension 2011; 57:413-20.

Perry CM. Azilsartan medoxomil . Clin Drug Invest 2012; 32:621-39.

Datar PA, Aher SB, Washimkar MH, Auti PB. 2DQSAR of novel 1, 4-dihydropyridine derivative blocking n-type-calcium channels. J Chem Pharm Res 2012; 4:1117-22.

Rupareliya RH, Joshi HS, Stability indicating simultaneous validation of Telmisartan and Cilnidipine with forced degradation behavior study by RP-HPLC in tablet dosage form 2013, ISRN chromatography; article ID 461461:1-6.

Iyer RP, Lindsey ML, Chilton RJ. A two for one bargain: Using Cilnidipine to treat hypertension and its comorbidities. Am J Hypertens 2013; 15:1-5.

Takahara A, Nakamura Y, Wagatsuma H, Aritomi S, Nakayama A, Satoh Y, Akie Y, Sugiyama A. Long‐term blockade of L/N‐type Ca2+ channels by Cilnidipine ameliorates repolarization abnormality of the canine hypertrophied heart. Br J Pharmacol 2009; 158:1366-74.

Fujii S, Kameyama K, Hosono M, Hayashi Y, Kitamura K. Effect of Cilnidipine, a novel dihydropyridine Ca++ -channel antagonist, on N-type Ca++ channel in rat dorsal root ganglion neurons. J Pharmacol Exp Ther 1997; 280:1184-91.

Hosono M, Fujii S, Hiruma T, Watanabe K, Hayashi Y, Ohnishi H, Takata Y, Kato H, Inhibitory effect of Cilnidipine on sympathetic neurotransmission and subsequent vasoconstriction in spontaneously hypertensive rats, Jpn J Pharmacol 1995; 69(2):127-34.

Shrinivasan R, Kamal Chandra J, Kumar R, Dushyant Kumar N, Stability indicating RP-HPLC method for determination of Azilsartan medoxomil in bulk and its dosage form, IJPAR 2014; 3(4):445-452.

Masthanamma S K, Jahnavi P, Stability indicating RP-HPLC method for determination of Azilsartan medoxomil in pharmaceutical dosage form, Research Journal of Pharmacy and Technology 2014; 7(2):168-172.

Sreenivasulu J, Venkata Ramana P, Reddy SG, Nagaraju CH VS, Thirumalai Rajan ST, and Eswaraiah S, A Rapid novel HPLC method for estimation of eight related compounds in Azilsartan Kamedoxomil and identification of degradation compounds by using LC-MS, Journal of Chromatographic Science 2015; 53:1463–1474.

Naazneen S, Sridevi A, Stability-indicating RP-HPLC method for the simultaneous estimation of Azilsartan medoxomil and Chlorthalidone in solid dosage forms, Int J Pharm Pharm Sci 2014; 6(6):236-243.

Aher SS, Saudagar R B, Kothari H, Development and validation of RP-HPLC method for simultaneous estimation of Azilsartan medoxomil and Chlorthalidone in bulk and tablet dosage form, Int J Curr Pharm Res 2018; 10(6): 21-24.

Pawar VT, Pawar S V, More HN, Kulkarni AS, Gaikwad DT, RP-HPLC method for simultaneous estimation of Cilnidipine and Chlorthalidone, J. Pharm. and Tech 2017; 10(11): 3990-3996.

Satyavati D, Kumar AG, Latha MB, Madhukar A, Validated RP-HPLC method for simultaneous estimation of Chlorthalidone and Cilnidipine in API and tablet dosage form, J Sci Res Pharm 2018; 7(11):124-129.

Sunitha N, Marihal SC, Sravanthi SJ, Venu A, Narasimha Rao BV, and Appa Rao B, Method development and validation of RP-HPLC method for the simultaneous estimation of Olmesartan and Cilnidipine in bulk and formulations, IJPRAS 2015; 4(3):127-135.

Araujo P. Key aspects of analytical method validation and linearity evaluation. J Chromatogr B 2009; 877:2224-34.

Lakshmi B, Reddy TV. A novel RP-HPLC method for the quantification of linagliptin in formulations. J At Mol 2012; 2:155.

Joshi R, Sharma R. Development and validation of RP-HPLC method for simultaneous estimation of three-component tablet formulation containing acetaminophen, chlorzoxazone, and aceclofenac. Anal Lett 2008; 41:3297-308.

Vander Heyden Y, Nijhuis A, Smeyers-Verbeke J, Vandeginste BG, Massart DL. Guidance for robustness/ruggedness tests in method validation. J Pharm Biomed Anal 2001; 24:723-53.

Ferreira SL, Caires AO, Borges TD, Lima AM, Silva LO, dos Santos WN. Robustness evaluation in analytical methods optimized using experimental designs. Microchem J 2017; 131:163-9.

Patel SN, Hinge MA, Bhanushali VM. Development and validation of a UV spectrophotometric method for simultaneous determination of Cilnidipine and chlorthalidone. J Pharm Res 2015; 9:41-5.

Uhrovcik J. Strategy for determination of LOD and LOQ values–Some basic aspects. Talanta 2014; 119:178-80.

Jain JJ, Patel SA, Development and validation of spectrophotometric method For simultaneous estimation of Azilsartan Kamedoxomil and Cilnidipine in the synthetic mixture, World Journal of Pharmaceutical Research 2018; 7(8):948-958.

Rao AL, Eswarudu MM, Vijay K, Bioanalytical method development and validation for simultaneous determination of Chlorthalidone and Cilnidipine drugs in human plasma by RP-HPLC 2019; 9(1):33-44.

Swaikar L, Kapupara P, Development and validation of stability indicating RP-HPLC method for estimation of Chlorthalidone and Cilnidipine in combined pharmaceutical dosage form, Research J. Pharm. And Tech 2020; 13(5):2376-2380.

Aruna G, Bharathi K, Kvsrg Prasad, Development and validation of bioanalytical HPLC method for simultaneous estimation of Cilnidipine and Nebivolol in human plasma, Int J Pharm Pharm Sci 2017; 9(10):253-259.

Minase AS, Dole MN, Sawant SD, Development and validation of an analytical method for simultaneous estimation of cilnidipine and olmesartan medoxomil in bulk and tablet dosage form by RP-HPLC, Int J Pharm Pharm Sci 2014; 6(7):508-511.

Vekariya PP, Joshi HS, Development and validation of RP-HPLC method for Azilsartan Medoxomil Potassium quantitation in human plasma by solid-phase extraction procedure, ISRN Spectroscopy, 2013; 1-6.

Jani R J, Patel S A, Spectrophotometric method for simultaneous estimation of Azilsartan Kamedoxomil and Cilnidipine in the synthetic mixture, Int. J. Pharm. Pharm. Sci. 2018; 3(2):86-90.

Sawaikar L, Kapupara P, Development and validation of a stability-indicating RP-HPLC method for the estimation of Chlorthalidone and Cilnidipine in combined pharmaceutical dosage form, Research J. Pharm. and Tech 2020; 13(5):2376-2380.

Published

02-11-2021

How to Cite

ANDHALE, S. M., & G. NIKALJE, A. P. (2021). SIMULTANEOUS ESTIMATION OF AZILSARTAN AND CILNIDIPINE IN BULK BY RP-HPLC AND ASSESSMENT OF ITS APPLICABILITY IN MARKETED TABLET DOSAGE FORM. International Journal of Applied Pharmaceutics, 14(1). https://doi.org/10.22159/ijap.2022v14i1.42208

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