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Current Pharmaceutical Analysis

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ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

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Research Article

RP-HPLC In-Vitro Dissolution Method Development and Validation for Determination of Olmesartan Medoxomil, Chlorthalidone and Cilnidipine Drug Combinations

Author(s): Pranavkumar Shah and Bhavin Dhaduk*

Volume 18, Issue 6, 2022

Published on: 30 March, 2022

Page: [629 - 641] Pages: 13

DOI: 10.2174/1573412918666220131114138

Price: $65

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Abstract

Objective: A simple, sensitive, and accurate in-vitro dissolution method has been developed for Olmesartan Medoxomil (OLM), Chlorthalidone (CHLR) & Cilnidipine (CIL) drug combination according to USP dissolution testing methodologies with different discriminating mediums and validated as per ICH guidelines.

Methods: The in-vitro dissolution profile was obtained using 900 ml of phosphate buffer pH 6.8 with 1.0% SLS at 37 °C ± 0.5 °C as dissolution medium and USP II (paddle) at 75 rpm. The average % in-vitro drug release was above 80% within 45 minutes for the above drug combination. The drug release profile was evaluated by RP-HPLC method. Chromatographic separation was done on Hypersil-BDS C-18 (12.5cm x 4.6mm x 5μm) column using gradient program with initial mobile phase ratio of 55:45 (v/v) mixture of ammonium acetate buffer (pH 5.0) and acetonitrile at a flow rate of 1.0 ml/min with detection wavelength 260 nm.

Results: The method was validated with respect to specificity, linearity, precision, accuracy, and robustness. The method was found to be linear in the range of 7.0-21.0 μg/ml for CHLR (R2 = 0.9982), 22.5-67.5 μg/ml for OLM (R2 = 0.9999) and 5.5 -16.5 μg/ml for CIL (R2 = 0.9995) respectively. The % recovery data were found between 98.3 % to 104.1%. The % RSD for method and intermediate precision of method did not exceed more than 2%.

Conclusion: The proposed in-vitro method can be applied successfully for routine quality control analysis to check the quality of above drug combination.

Keywords: Olmesartan medoxomil, chlorthalidone, cilnidipine, in-vitro drug release, ICH guidelines, dissolution method.

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[1]
Dressman, J.B.; Amidon, G.L.; Reppas, C.; Shah, V.P. Dissolution testing as a prognostic tool for oral drug absorption: Immediate release dosage forms. Pharm. Res., 1998, 15(1), 11-22.
[http://dx.doi.org/10.1023/A:1011984216775] [PMID: 9487541]
[2]
Sariasan, S.; Kayar, G.; Golkalp, M.; Dud, U.; Knezevic, Z.; Dayan, N.; Onal, C. Determination and application of biorelevant dissolution media to meet the in-vivo performance in valsartan and chlorthalidone in the solid dosage form. Int. J. Pharm. Sci. Res., 2019, 10(11), 4853-4860.
[3]
Rockville, M.D. Food and Drug Administration, Guidance for Industry. Dissolution testing of immediate-release solid oral dosage forms. United States food and drug administration, 1997, 1-7. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dissolution-testing-immediate-release-solid-oral-dosage-forms
[4]
Rao, N.; Kumar, R.; Kulkarni, U.; Kumar, R. Comparative study on the effect of different techniques used in the development of chlorthalidone fast-dissolving tablets. Int. J. Pharm. Sci. Res., 2010, 1(2), 78-87.
[5]
Krishana, M.; Rao, S.V.; Venugopal, N.V.S.; Mantena, P.V.B. In-vitro dissolution method for alendronate sodium and vitamin D3 tablets using HPLC with a combination of refractive index and ultraviolet detectors. Anal. Chem. Lett., 2015, 5(4), 216-228.
[http://dx.doi.org/10.1080/22297928.2015.1090331]
[6]
Ghadi, R.; Dand, N. BCS class IV drugs: Highly notorious candidates for formulation development. J. Control. Release, 2017, 248(1), 71-95.
[http://dx.doi.org/10.1016/j.jconrel.2017.01.014] [PMID: 28088572]
[7]
Amidon, G.L.; Lennernäs, H.; Shah, V.P.; Crison, J.R. A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res., 1995, 12(3), 413-420.
[http://dx.doi.org/10.1023/A:1016212804288] [PMID: 7617530]
[8]
Pimple, S.; Joshi, A.; Maurya, P.; Swami, A.; Digge, M.; Singh, R. Formulation development and optimisation of Olmesartan Medoxomil immediate-release tablets. Int. J. Pharm. Sci. Res., 2015, 7(5), 395-400.
[9]
Aher, S.S.; Saudangar, R.B.; Kothari, H. Development and validated RP-HPLC dissolution method for simultaneous detection of azilsartan-chlorthalidone in the tablet dosage form. Int. J. Curr. Pharm. Res., 2015, 10(6), 21-24.
[http://dx.doi.org/10.22159/ijcpr.2018v10i6.30967]
[10]
Kumar, K.K.; Sharma, K.P.; Srinivas, L. development of agglomerated crystals of olmesartan medoxomil by spherical crystallization technique for enhancing the micrometric and solubility property. World J. Pharm. Res., 2016, 5(3), 646-675.
[11]
Agarwal, G.; Agarwal, S.; Kamboj, R.; Karar, P.K. Formulation and evaluation of orodispersible tablet of cilnidipine by sublimation method. World J. Pharm. Res., 2016, 4(11), 153-159.
[12]
Rao, D.; Venkateswarlu, T.; Krishna, G. Development, and validation of HPLC method of a dissolution test for metoprolol succinate and cilnidipine. Int. J. Pharm. Biol. Sci., 2015, 5(4), 971-981.
[13]
Siju, V.V.; Soniwala, M.; Nagar, S. A novel technique to enhance the dissolution rate of cilnidipine using liquid-solid compact & wet granulation. Int. J. Pharm. Sci. Drug Res., 2017, 9(4), 160-168.
[http://dx.doi.org/10.25004/IJPSDR.2017.090402]
[14]
Prajapati, S.T.; Maheshwari, P.D.; Patel, C.N. formulation, and evaluation of orodispersible tablets of cilnidipine by spray drying technique. World J. Pharm. Res., 2015, 4(5), 1526-1539.
[15]
Bajerski, L.; Rossi, R.C.; Dias, C.L.; Bergold, A.M.; Fröehlich, P.E. Development and validation of a discriminating in vitro dissolution method for a poorly soluble drug, olmesartan medoxomil: Comparison between commercial tablets. Aaps Pharmscitech.,, 2010, 11(2), 637-644.
[http://dx.doi.org/10.1208/s12249-010-9421-0] [PMID: 20373150]
[16]
Karuppiah, S.P.; Basha, K. A dissolution development and evaluation of marketed formulation for anti-hypertensive drug-olmesartan medoxomil. Int. J. Pharm. Sci. Res., 2017, 43(1), 231-236.
[17]
Dhaduk, B.B.; Patel, C.B.; Parsania, P.H. reverse-phase high-performance liquid chromatographic method development for simultaneous determination of biologically active and thermally stable 1,1′-bis(3-methyl-4-hydroxyphenyl) cyclohexane and 1,1′-bis(3,5-dibromo-4-hydroxyphenyl) cyclohexane. Der Chem. Sini., 2016, 6(4), 62-67.
[18]
Nayak, P.R.; Chaudahary, A.B.; Rahevar, N.M. RP-HPLC method development and validation for simultaneous estimation of chlorthalidone, cilnidipine and olmesartan in tablet dosage form. World J. Pharm. Res., 2016, 5(6), 1498-1508.
[19]
Sawale, V.; Dangre, P.; Dhabarde, D. Development and validation of RP-HPLC method for the simultaneous estimation of olmesartan medoxomil and chlorthalidone in tablet dosage form. Int. J. Pharm. Pharma, 2015, 7(5), 266-269.
[20]
Vartak, J.P.; Roy, S.M.N. Simultaneous determination of clinidipine, olmesartan medoxomil and chlorthalidone in pharmaceutical preparations using validated, LCMS compatible RP-HPLC method. Anal. Chem. Ind. J., 2015, 15(3), 105-110.
[21]
Shah, P.; Dhaduk, B. Related impurities high-performance liquid chromatography method development and validation for drug combinations: Olmesartan medoxomil, chlorthalidone & cilnidipine. Int. J. Pharm. Sci. Res., 2020, 12(1), 1-10.
[22]
Rao, C. Development and validation of stability indicating LC method for olmesartan medoxomil. Am. J. Anal. Chem., 2012, 3(2), 153-160.
[http://dx.doi.org/10.4236/ajac.2012.32022]
[23]
Hinge, M.A. Development and validation of UV spectrometric method for simultaneous determination of Cilnidipine and Chlorthalidone. J. Pharm. Res., 2015, 9(1), 41-45.
[24]
Butle, S.R.; Deshpande, P.B. Development and validation of stability indicating HPTLC method for simultaneous determination of telmisartan and cilnidipine in combined tablet dosage form. Int. J. Pharm. Sci. Drug Res., 2015, 7(6), 478-483.
[25]
Chai, R.; Gao, H.; Ma, Z.; Guo, M.; Fu, Q.; Liu, H.; He, Z. In vitro and in vivo evaluation of olmesartan medoxomil microcrystal and nanocrystals: Preparation, characterization, and pharmacokinetic comparison in beagle dogs. Curr. Drug Deliv., 2019, 16(6), 500-510.
[http://dx.doi.org/10.2174/1567201816666190627143214] [PMID: 31244438]
[26]
Sathali, A.A.H.; Jaylakshmi, J. Enhancement of solubility and dissolution rate of olmesartan medoxomil by solid dispersion technique. J. Curr. Chem. Pharm. Sci., 2013, 3(2), 123-134.
[27]
Siju, V.V.; Soniwala, M.; Nagar, S. A novel technique to enhance dissolution rate of cilnidipine using liquisolid compact & wet granulation. Int. J. Curr. Pharm. Res., 2017, 9(4), 160-168.
[28]
Rao, N.G.R.; Kumar, K.R. Design of fast dissolving tablets of Chlorthalidone using novel co-processed super disintegrants. J. Chem. Pharm. Res., 2010, 2(4), 671-679.
[29]
Rockville: Convection. Dissolution, 34th ed; United States Pharmacopoeia, 2011, pp. 1-8.
[30]
Gohel, M.C.; Sarvaiya, K.G.; Shah, A.R.; Brahmbhatt, B.K. Mathematical approach for the assessment of similarity factor using a new scheme for calculating weight. Indian J. Pharm. Sci., 2009, 71(2), 142-144.
[http://dx.doi.org/10.4103/0250-474X.54281] [PMID: 20336213]
[31]
Kassaye, L.; Genete, G. Evaluation and comparison of in-vitro dissolution profiles for different brands of amoxicillin capsules. Afr. Health Sci., 2013, 13(2), 369-375.
[http://dx.doi.org/10.4314/ahs.v13i2.25] [PMID: 24235938]
[32]
Dhaduk, B.B.; Patel, C.P.; Parsania, P.H. Reverse phase high-performance liquid chromatographic method development for simultaneous determination of biologically active and thermally stable 1,1′-bis(3-methyl-4-hydroxyphenyl) cyclohexane and 1,1′-bis(3,5-dibromo-4-hydrophenyl) cyclohexane. Der. Chemica. Sinica, 2015, 6(4), 62-71.
[33]
Validation of analytical procedures: text and methodology Q2(R1) 2005, 1994(1) Available from: https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf

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