DEVELOPMENT AND VALIDATION OF STABILITY INDICATING REVERSE PHASE HIGH‑PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF ATENOLOL, HYDROCHLOROTHIAZIDE AND LOSARTAN IN BULK AND PHARMACEUTICAL DOSAGE FORM
Abstract
ABSTRACT
Objective: The objective of present work was to develop and validate a simple, fast, precise, selective and accurate reverse phase high-performance
liquid chromatography method for the simultaneous determination atenolol (ATN), hydrochlorothiazide (HCTZ) and losartan (LOS) in a
pharmaceutical dosage form.
Methods: The separation of these three drugs was achieved on an SHISHEDO C
, 250 mm × 4.6 mm, 5 µ size column with a mobile phase consisting
of acetonitrile and 0.5% orthophosphoric acid (30:70 v/v) at a flow rate of 1 ml/minute and UV detection at 224 nm.
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Results: The retention times were observed to be 2.242, 3.963 and 6.733 minutes for ATN, HCTZ and LOS, respectively. Linearity was found to be
4-12 μg/ml, 4-12 μg/ml, 1-3 μg/ml for ATN, HCTZ and LOS, respectively. The method was statistically validated for linearity, recovery, the limit of
detection (LOD), limit of quantification (LOQ), accuracy and precision. The stress testing of the drugs individually and their mixture is carried out
under acidic, alkaline, oxidation, photo-stability and thermal degradation conditions and its degradation products is well-resolved from the analyte
peaks.
Conclusion: This method was successfully validated for accuracy, precision, and linearity, LOD and LOQ.
Keywords: Atenolol, Hydrochlorothiazide, Losartan, Reverse phase high-performance liquid chromatography.
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References
REFERENCES
Data Base of Atenolol, Compilation Prepared by Drug Bank. Available
from: http://www.Drug bank.ca/drugs/DB00335.
Data Base of Hydrochlorothiazide, Compilation Prepared by Drug
Bank. Available from: http://www.Drug bank.ca/drugs/DB00999.
Data Base of Losartan, Compilation Prepared by Drug Bank. Available
from: http://www.Drugbank.ca/drugs/db00678.
Erk N. Application of first derivative UV-spectrophotometry and
ratio derivatives spectrophotometry for simultaneous determination
of candesartan cilexetil and hydrochlorothiazide. Pharmazie
;58:796-800.
Bhatia NM, Desai RB, Jadhav SD. Simultaneous estimation of losartan
potassium and hydrochlorothiazide from tablets by first order derivative
spectroscopy. Int J Pharm Pharm Sci 2013;5(1):464-6.
Bari S, Sathe S, Jain P, Surana S. Spectrophotometric method for
simultaneous estimation of atenolol in combination with losartan
potassium and hydrochlorothiazide in bulk and tablet formulation.
J Pharm Bioallied Sci 2010;2(4):372-5.
Selvadurai M, Meyyanathan SN. Sensitive and accurate estimation
of losartan potassium formulation by high-performance thin-layer
chromatography. Pharm Methods 2011;2(2):95-8.
Kolsure AK, Chavan BB, Chabukswar AR, Kuchekar BS. Development
and validation of HPTLC method for simultaneous estimation of
atorvastatin calcium and losrtan potassium in combined dosage form. J
Med Pharm Innov 2014;1(4):58-61.
Lakshmi KS, Lakshmi S. Simultaneous analysis of losartan potassium,
amlodipine besylate and hydrochlorothiazide in bulk and in tablets
by high-performance thin layer chromatography with UV-Absorption
densitometry. J Anal Methods Chem 2012;4(2):85-91.
Sathe SR, Bari SB. Simultaneous analysis of losartan, atenolol and
hydrochlorothiazide in bulk and in tablets by HP-TLC with UV
absorption densiometry. Acta Chromatogr 2007;19(2):53-62.
Chaudhari V, Hussian S, Ubale M. A newer validated and
stability indicating HPLC method for estimation of atenolol and
hydrochlorothiazide in bulk and dosage form. Chem J 2013;1:93-101.
Ravisankar P, Kand Pavan G. Development and validated RPHPLC
method for
simultaneous determination
of
atenolol and
hydrochlorothiazide
in
tablet
dosage form. Int J Pharm Chem Biol Sci
;5(3):665-75.
Mhaske RA Sahasrabudhe S, Mhaske AA. RP-HPLC method for
simultaneous determination of irbesartan, losartan, hydrochlorothiazide
and chlorthalidone-application to commercially available drug
products. Int J Pharm Sci Res 2012;3(4):1116-23.
Rani VP, Patil KR, Sangshetti JN, Yeole RD, Shinde DB. Stability
indicating LC method for simultaneous determination of irbesartan and
hydrochlorothiazide in pharamaceutical preparations. J Chromatogr Sci
;39(4):91-101.
Gavini R, Puranik SB, Kumar GV, Sridhar KA. Development and
validation of stability indicating RP-HPLC method for simultaneous
estimation of amlodipine and losartan in bulk and tablet dosage
formulation. Int Res J Pharm 2012;3(11):18-22.
Indrani B, Basak S, Maity A, Ghosh SK. Isolation and characterization
of acid and base degradation products in atenolol, hydrochlorothiazide
and a validated stability indicating HPLC-UV method for their
quantification. Int J Adv Pharm Anal 2015;5(2):36-41.
Tengali AR, Shivakumar G, Gurupadayya BM. UPLCMS method
development and validation of amlodipine, hydrochlorothiazide
and losartan in combined tablet dosage form. Am J Anal Chem
;6:228-38.
Yadav SS, Rao JR. Simultaneous estimation of losartan,
hydrochlorothiazide and atenolol from solid dosage form by RP-HPLC.
Int J Pharm Pharm Sci 2014;6(1):53-62.
Tengali AR, Gurupadayya BM. Method development and validation of
tablet dosage form containing losartan, atenolol, hydrochlorothiazide
using internal standard by RP-HPLC. J Chromatogr Sep Tech
;2(5):78-86.
Kavitha J, Muralidharan S. Development and validation of new method
for atenolol, hydrochlorothiazide and losartan potassium by RP-HPLC:
Its application to routine quality control analysis. Int J ChemTech Res
;2(2):15-21.
Partiban C, Bhagavan Raju M, Sudhakar M. Simultaneous estimation
and validation of atenolol, hydrochlorothiazide and losartan in
tablet dosage form by RP-HPLC method. Int J Pharm Indian Res
;1(4):62-9.
Asian J Pharm Clin Res, Vol 9, Issue 2, 2016, 118-124
Neelima et al.
Sharma R, Khanna S, Sharma GP. RP-HPLC method for Simultaneous
estimation of atenolol, hydrochlorothiazide and losartan in tablet
dosage form. Chem Sci Trans 2013;4(1):58-63.
Halvadar Freddy H, Vairal Dharmendra L. RP-HPLC method for
Simultaneous estimation of atenolol, hydrochlorothiazide, losartan
and valsartan in the pharmaceutical dosage form. Int J Pharm Life Sci
;1(5):282-89.
Kolhal S, Lokhande R, Sutar R, Surve S. A validated RP-HPLC method
for simultaneous determination of multicomponent dosage form
containing amlodipine, telmisartan, hydrochlorothiazide, atenolol and
losartan. Int J Pharm Sci Rev Res 2014;25(2):154-59.
Abdussaleem K, Boopathy D, Perumal P. Analytical method
development and validation of losartan potassium and atenolol
in combined dosage form by RP-HPLC. Int J Pharm Tech Res
;2(1):471-74.
del Rosario Brunetto M, Contreras Y, Clavijo S, Torres D, Delgado Y,
Ovalles F, et al. Determination of losartan, telmisartan, and valsartan
by direct injection of human urine into a column-switching liquid
chromatographic system with fluorescence detection. J Pharm Biomed
Anal 2009;50:194-99.
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