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Mangte, D.V. and Deshmukh, S.P., Indian J. Chem., 2006, 45B,

Accepted 10 April 2007
12.
d ub
Mangte, D.V. and Deshmukh, S.P., J. Indian Chem. Soc., 2006,
83, 517. Revised 14 July 2006
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82, 2807. Indian J. Pharm. Sci., 2007, 69 (2): 295-298
14. Varma, R., Kulkarni, S.Y., Jose, C.I. and Pansare, V.S., Carbohydr.
r
fo kno .co
ble ed ow
RP-HPLC Method for
RP-HPLC i M dkn
la Simultaneous Estimation of
a by e
Telmisartan andavHydrochlorothiazide in Tablet
Tablet
Dosage Form is ted w.
m
F os ww
PD te h (
S. B. WANKHEDE*, M. R. TAJNE, K. R. GUPTA AND S. G. WADODKAR
is si
University Department of Pharmaceutical Sciences, Nagpur University, Nagpur - 440 033, India.
h
T a
The present work describes a validated reverse phase high performance liquid chromatographic method for
simultaneous estimation of telmisartan and hydrochlorothiazide in tablet formulation. Chromatography was
performed on a ODS Hypersil C18 (25 cm×4.6 mm I.D) column from thermo in isocratic mode with mobile
phase containing acetonitrile:0.05 M KH2PO4 pH 3.0 (60:40). The flow rate was 1.0 ml/min and the eluent was
monitored at 271 nm. The selected chromatographic conditions were found to effectively separate telmisartan
(RT- 5.19 min) and hydrochlorothiazide (RT- 2.97 min). Linearity for telmisartan and hydrochlorothiazide were
found in the range of 4.1-20.48 µg/ml and 1.28-6.4 µg/ml, respectively. The proposed method was found to be
accurate, precise, reproducible and specific and can be used for simultaneous analysis of these drugs in tablet
formulation.

*For correspondence Telmisartan is 41-[1,41-dimethyl-21-propyl-[2,61-bi-1H-
E-mail: sagar2277@rediffmail.com benzimidazole]-11-yl)methyl][1,11-biphenyl]-2-carboxylic
S. B. Wankhede, c/o. R. N. Sakpal, Rachana Appartment, acid and hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-
Pavnaskar Layout, Tope Nagar, Amravati - 444602, India. 1,2,4-benzothiadiazine-7-sulphonamide-1,1-dioxide.
298 Indian Journal of Pharmaceutical Sciences March - April 2007

298 CMYK

15. alkaline (0. recovery experiments were carried study the accuracy. 25 µl Hamilton injecting syringe and window based single channel software was o o fo ntablet . Fig. Raisen. The solution was filtered formulation contains telmisartan and hydrochlorothiazide through whatman filter paper no. The stress s The solvents acetonitrile andi methanol e w t Potassium used in the conditions applied were acidic (0.0 ml volumetric flask. 1: A typical chromatogram of telmisartan (RT.1 M HCl). an ODS Hypersil C-18 rethe proposed ) r f out. Pure drug samples of telmisartan and k hydrochlorothiazide e w hydrochlorothiazide were procured froml Aristo d fourodifferent levels (about 10.April 2007 Indian Journal of Pharmaceutical Sciences 299 CMYK299 . precision and reproducibility of loop). 20µl e To P . preparation was injected into injector of liquid Hydrochlorothiazide in combination with other drugs is chromatograph and chromatography was performed on reported to be estimated by spectrophotometric4.0siby using(600orthophosphoric stress conditions for 24 h.48 µg/ml of telmisartan and 1. Accurately weighed quantity of tablet powder in combination with hydrochlorothiazide. From the mean peak drugs in tablets. Telma-H (Glenmark) and Telpress-H (Nicolas Piramal) d was found out. The tablet a b e n The amount of drug recovered by the proposed il M formulations k claim).ijpsonline. The analytical method for simultaneous a mixture of acetonitrile:0.6 mg) and hydrochlorothiazide (8 mg) was transferred to a standard 50 ml volumetric flask. www. The eluent was monitored at 271 nm. Twenty tablets were weighed and for the treatment of essential hypertension usually given powdered.8045 g in 1000 the pH was adjusted s i to 3. 1. and HPLC3 method for estimation of hydrochlorothiazide.5 mg.6 mm ID). added 25 ml of methanol and hypertension.com Telmisartan is a new angiotensin II receptor antagonist formulations. The so prepared stock solution was further diluted with mobile phase to get a final concentration range of 4. The present work describes a validated reverse phase a d ns typical chromatogram of telmisartan and hydrochlorothiazide is shown in fig.7 methods. Plotting a graph of peak area vs. 7725. After exposing the samples to above mentioned dissolving 6. Literature survey revealed then appropriately diluted with mobile phase to get a final linear sweep polarography1. Accurately weighed quantity of telmisartan (25. well tolerated with a lower incidence of shaken for ten minutes. the samples were diluted. concentration allowed the checking of linearity of detector response.05 M KH2PO4 (60:40 v/v) as determination of telmisartan and hydrochlorothiazide in mobile phase. Also o 2 2 heat (60 ) and UV-exposure for 24 h was P ml tofedouble distilled water and studied.6 mm I. SPD-10A UV/Vis detector. 20 and 25% of labeled solution form) were added at Pharmaceuticals Ltd. ODS Hypersil C-18 RP column (25 cm×4. The results of recovery studies are va andby40 mg e shown in Table 2..cpowder. m deliberately degrading the tablet sample. the volume was then adjusted to cough than ACE inhibitors. acid.D) using m rf o HPLC6.1 os investigation were of HPLCFgrade (Merck). parallel catalytic hydrogen concentration of 8 µg/ml of telmisartan and 2. An isocratic HPLC system (Shimadzu) consisting of LC.05 M) h was ( w prepared h.10-20.5 mg telmisartan hydrochlorothiazide were obtained froma localddrug stores. (instandard telmisartan and used. w lic area of telmisartan and hydrochlorothiazide the amount of o drug in tablet was computed (Table 1).5 µg/ml of wave method2.19) and Assay was performed on two different marketed hydrochlorothiazide (RT-2. Twenty micro liters of sample telmisartan alone in pharmaceutical preparations.5. dissolved and diluted to the mark with methanol. 41 and the filtrate was in the ratio of 40:12.5. A pharmaceutical formulation has not been reported so far. Specificity studies were carried out by with a labeled claim of 12. The marketed tablet mark with methanol and mixed. . Rheodyne injector (2E.28-6. d ub 10AT liquid pump. Each sample was o HPLC method for simultaneous determination of these nl atio injected and analysed in triplicate.4 µg/ml of hydrochlorothiazide.97) March . wTo an accurately method m weighed quantity of pre-analyzed RP column (25 cm×4. Buffer (400h T aml) and acetonitrile ml) were mixed and filtered through 45 µ filter paper and sonicated. The combination equivalent to about 25 mg of telmisartan was transferred is useful in the treatment of mild to moderate to 50. w by 24M NaOH) and oxidizing condition (3% H O ) at 50 foro dihydrogen phosphateD (0.

. Pharm. J. concentration was found to be linear in the range of Pharm..S.91 1.5 40. r obtained under different stress conditions are as follows: f ACKNOWLEDGEMENTS w om r o o The authors c are thankful to Head.96%) (telmisartan. Department of 98. Indian J. Katakdhond. Veerasekaran. K.R.3420 for telmisartan and 6410 for M.98 for system suitability parameters 3.43%y and d Pharmaceuticals Oxidizing (telmisartan. Thfactor. ) . The results e e P routine analysis of these drugs in combination tablets. 89.J. r= Accepted 11 April 2007 0.1 N NaOH) the fpeak kn acidic (telmisartan. V. M... 38.60 ±0.60%).88 Telpress-H 40 12. and Geetha. hydrochlorothiazide. 69 (2): 298-300 respectively.71 2..15 99.24 for hydrochlorothiazide) indicate the ±0.91 0.19 min) andshydrochlorothiazide i of telmisartan i are as follows: resolution- (2.15% and hydrochlorothiazide- w .B. 38.660 12.V..13%±0. Pharm.00 98. 2001. hydrochlorothiazide.917 for hydrochlorothiazide.472 12. and Yaodong. S.98. The plot of peak area vs. Amount of drug Amount of drug % recovery precision and reproducibility of the proposed method.a4. Nagpur for area of telmisartan and hydrochlorothiazide is lfound b e n o la increase by ten folds and five folds.48 µg/ml for telmisartan and 1. Shankar. Rajesh.37 for 5.97 min).312 101. Anal.48% and hydrochlorothiazide- facilities for the research work and Aristo Ltd. w Sciences. reproducible and specific and can be used for filtered and analyzed in similar manner as described under assay of marketed formulation.88 o nl atio Mean percent recovery* SD 99. Sci.S. 2003.101.50 ±0.ijpsonline. M.. 2004. Junfeng. Biomed. L. 681.April 2007 300 CMYK . plates/column.88 99. in alkaline condition (0.. G.11 99.99.647 for telmisartan Indian Drugs.80%)a and uv-exposure m REFERENCES is sted98. d ub precise. The mean recoveries of telmisartan and Revised 26 July 2006 Received 7 November 2005 hydrochlorothiazide were 99. Palled.com TABLE 1: RESULTS OF ANALYSIS OF TABLET FORMULATION Tablet formulation Label claim (mg/tablet) Amount of drug estimated* % of label claim*±SD (mg/tablet) TEL HTZ TEL HTZ TEL HTZ Telma-H 40 12. Kanumulu. and Janhavi.60 variation (±0. a v b e of the drugs.44 for telmisartan and ±0 . J. Mehta... Nagpur University.620.89 3.18 98..18 for 3. F. Based on the above results it *mean of four observations o w lic can be concluded that the proposed method is accurate. Pharm.21 for telmisartan and 1.. Sci. Number of theoretical 5. hydrochlorothiazide. 24.49 99..48 99. capacity Pharm.14 7.89 ±0. Chatter.72. and Ning. 187. S.10-20.53 2.13 telmisartan and ±0.50 2. Sci. added (mg) recovered (mg) The robustness of the method was studied by carrying m out analyst to analyst and intra day variations The low rf o TEL HTZ TEL HTZ TEL HTZ 9. The values of percent recovery and low 300 Indian Journal of Pharmaceutical Sciences March .48%±0. 37.63% and hydrochlorothiazide- e to d Pharmaceutical. Abstr.93 0.36 values of standard deviation for analyst to analyst 7..85 ±0.97 1. 6. and 1. F. 108. P. R. 335.49 98.52 and 99. J.. Xu. Maotian.. 3808913 4. 67. R. 34.24%). 1676. The 2.K.. through Int. tailing factor.N..... Pharm. 2005.68 a d ns hydrochlorothiazide) and intra-day variation (1. Indian Drugs. 4. 38. 2000. Belal.32 100. Pharm. 2001. S. and Bhat. www. 9. 167. Indian J.4 µg/ml for hydrochlorothiazide (correlation coefficient for calibration curve of both telmisartan and hydrochlorothiazide. Indian J. Raisen for providing the gift samples 0 99.64 2. s 1465.98 ±0.. 7.5 39. 2000. L. heat (60 ) (telmisartan.1.A. Sci.76 9.51 5. Biomed. Junfeng S. for effective separation e (RT-5. 65. 2001. Mehta.28-6. Kadam.S.99). Bhatt. R.M.77 100. respectively. and Bhanu. 2007.102. Xu.498 99. A. M. Anal.09 98. F o was found w D The proposed chromatographic system h P and tquantitation (w suitable 1. M kproviding i 97. Maotian.83 robustness of the method.37 *mean of five observations TABLE 2: RESULTS OF RECOVERY STUDIES values of standard deviation indicate the accuracy.