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

Authors

  • Meesala Santhi Neelima
  • BONTHU MOHAN GANDHI Andhra University
  • Vatchavai Bhaskara Raju
  • Kamatham Srinivas Sumanth
  • Kolli Srinivas
  • Pasala Mounika
  • Pedaprolu Jhansi Naga Lakshmi

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.
18
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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Author Biography

BONTHU MOHAN GANDHI, Andhra University

Assistant Professor,

Department of Pharmaceutical Analysis & Quality Assurance

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.

Published

01-03-2016

How to Cite

Neelima, M. S., B. M. . GANDHI, V. B. Raju, K. S. Sumanth, K. Srinivas, P. Mounika, and P. J. N. Lakshmi. “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”. Asian Journal of Pharmaceutical and Clinical Research, vol. 9, no. 2, Mar. 2016, pp. 118-24, https://mail.innovareacademics.in/journals/index.php/ajpcr/article/view/10081.

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