SIMPLE ANALYTICAL METHOD FOR THE SIMULTANEOUS ESTIMATION OF HYDROCHLOROTHIAZIDE AND CANDESARTAN BY RP-HPLC
DOI:
https://doi.org/10.22159/ijap.2017v9i6.20727Keywords:
Hydrochlorothiazide, Candesartan, RP-HPLC, Method development, ValidationAbstract
Objective: To develop a simple, rapid, economic, accurate and precise reverse phase-high performance liquid chromatographic (RP-HPLC) method for the determination of hydrochlorothiazide and candesartan in the pharmaceutical dosage form and to validate as per international conference on harmonization (ICH) guidelines.
Methods: The chromatographic separation was performed on Silanol BDS C18 column (250 x 4.6 mm, 5 μm), a mobile phase consisting of water (pH adjusted to 2.8 with orthophosphoric acid): acetonitrile (30:70 % v/v), with a flow rate 1 ml/min and the detection wavelength of 210 nm using photodiode array (PDA) detector.
Results: The developed method resulted in elution of hydrochlorothiazide at 2.28 min and candesartan at 4.28 min. The calibration curves were linear (r2=0.999) in the concentration range of 6.25-18.75 μg/ml and 8-24 μg/ml for hydrochlorothiazide and candesartan respectively. The percentage recoveries were found to be 99.78-100.39 for hydrochlorothiazide and 99.87-100.64 for candesartan. The limit of detection (LOD) was found to be 0.410 μg/ml and 0.699 μg/ml for hydrochlorothiazide and candesartan respectively. The limit of quantitation (LOQ) was found to be 1.367 μg/ml and 2.330 μg/ml for hydrochlorothiazide and candesartan respectively.
Conclusion: A simple, economic, accurate, precise, linear and rapid RP-HPLC method was developed for simultaneous quantitative estimation of hydrochlorothiazide and candesartan in bulk and pharmaceutical formulation and the method was validated as per ICH guidelines. Hence, the method holds good for the routine analysis of hydrochlorothiazide and candesartan in various pharmaceutical industries as well as in academics.
Downloads
References
Mathrusri A, Mukthinuthalapati, Sai Phani Kumar J. Simultaneous derivative spectrophotometric determination of candesartan cilexetil and hydrochlorothiazide. Pharm Methods 2015;6:148-51.
Tamboli A, Jamadar M, Khan N, Manure J, Bathe R. UV-spectrophotometric determination of telmisartan and hydrochlorothiazide in combined tablet dosage form using simultaneous equation method. Int J Adv Pharm Anal 2014;4:18-22.
Chaitali T, Jyoti D, Pawar P. Simultaneous estimation and validation of losartan potassium and hydrochlorothiazide in bulk and tablet dosage form by using the different spectrophotometric method. Der Pharm Chem 2014;6:24-30.
Varsha R, Baheti G, Indraksha S, Dehghan M. Estimation of amlodipine besylate, valsartan and hydrochlorothiazide in bulk mixture and tablet by UV spectrophotometry. Indian J Pharm Sci 2012;74:18-23.
Bhadke Tejaswini K, Mohite Shrinivas K, Magdum Chandrakant S. Simultaneous estimation of candesartan cilexetil and hydrochlorothiazide in tablet dosage form by UV spectrophotometric method. Int J PharmTech Res 2012;4:786-90.
Gopala Swamy T, Nagaraju K, Lakshmana Rao A. Simultaneous estimation of telmisartan and hydrochlorothiazide in pharmaceutical dosage form. Int J Drug Dev Res 2011;3:362-8.
Patel J, Dave JB, Patel CN, Patel D. Q-analysis spectrophotometric methods for estimation of candesartan cilexetil and hydrochlorothiazide in tablet dosage form. J Chem Pharm Res 2010;2:10-4.
Bipin H, Sachin B. HPTLC-densitometric analysis of candesartan cilexetil and hydrochlorothiazide in tablets. J Planar Chromatogr Mod TLC 2008;21:173-6.
Vijaya Bharathi D, Kishore H, Pankaj K, Satyanarayana V, Venkateswarlu V. LC–MS/MS method for simultaneous estimation of candesartan and hydrochlorothiazide in human plasma and its use in clinical pharmacokinetics. Bioanalysis 2012;4:1195-204.
Revathi R, Saravanan V, Ethiraj T, Jhansi Lakshmi M. RP-HPLC analysis for quantitation of candesartan cilexetil in solid dosage forms. Asian J Pharm Anal 2013;3:115-8.
Subbarao DV, Radha Krishnan P, Suryanarayana MV, Himabindu V. A stability-indicating LC method for candesartan cilexetil. Chromatographia 2007;66:499-507.
Ayyakannu A, Gangadhara A, Raj A. HPLC method development and validation for simultaneous estimation of olmesartan medoxomil, hydrochlorothiazide and amlodipine besylate tablets. Pharm Lett 2015;7:182-96.
Rahul R, Narayanaswamy VB. Development of a RP-HPLC method for the simultaneous estimation of candesartan cilexetil and hydrochlorothiazide in pharmaceutical dosage forms. Int J Res Pharm Chem 2015;5:452-69.
Quatab S, Razzaq S, Ashfaq M, Shuja Z, Khan I. Simple and sensitive LC-UV method for simultaneous analysis of hydrochlorothiazide and candesartan cilexetil in pharmaceutical formulations. Acta Chromatogr 2007; 19:119-29.
Ananda Rao B, Surya Kumar T. Development and validation of an RP-HPLC method for estimation of hydrochlorothiazide and candesartan cilexetil in pharmaceutical dosage form. Int J Pharm 2013;3:166-9.
Mathrusri Annapurna M, Narendra A, Ravi kumar K. Liquid chromatographic method for the simultaneous quantitative determination of candesartan cilexetil and hydrochlorothiazide in pharmaceutical dosage forms. J Drug Delivery Ther 2012;2:48-54.
Balamuralikrishna K, Syamasundar B. Development and validation of a high performance liquid chromatographic method for the simultaneous estimation of candesartan cilexetil and hydrochlorothiazide in the combined tablet dosage form. Pharm Chem 2010;2:231-7.
Prasanthi C, Angala Parameswari S, Aruna G. Development and validation of a RP-HPLC method for metformin hydrochloride and nateglinide in bulk and combined dosage form. Int J Pharm Pharm Sci 2016;8:267-71.
International conference on harmonization tripartite guideline on validation of analytical procedures text and methodology: Q2 (R1); 2005.