A VALIDATED HPTLC METHOD FOR SIMULTANEOUS QUANTIFICATION OF NEBIVOLOL AND HYDROCHLOROTHIAZIDE IN BULK AND TABLET FORMULATION
Abstract
A HPTLC method for the estimation of Nebivolol (NBV) and Hydrochlorothiazide (HCTZ) has been developed. It employs aluminum backed silica gel 60 F254 TLC plates, (20 cm × 10 cm, layer thickness 0.2 mm) pre-washed with methanol and mobile phase comprising of 1,4-dioxane: toluene: triethylamine (5:3:0.1 v/v). The developing solvent was run up to 80 mm in Camag chamber previously saturated with 10.0 ml of solvent mixture for 30 min. Densitometric scanning was then performed with Camag TLC Scanner-3 equipped with winCATS (version 1.3.0) at λ max 281 nm. The Rf values were found to be 0.75 and 0.43 for Nebivolol and Hydrochlorothiazide respectively. The limit of detection and limit of quantitation were found to be 43ng/spot & 130ng/spot for Nebivolol and 25ng/spot & 76ng/spot for Hydrochlorothiazide respectively. The % RSD of intra-day variation and inter day variation were 0.54 and 0.41 respectively for NBV and 0.46 and 0.39 for HCTZ respectively. The proposed method can also be used for routine quality control to accurately determine Nebivolol and Hydrochlorothiazide in bulk and tablet dosage form.
Keywords:
HPTLC, Nebivolol (NBV), Hydrochlorothiazide (HCTZ), analytical method development, method validation.DOI
https://doi.org/10.25004/IJPSDR.2011.030115References
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7. Sahoo M K, Giri RK, Barik CS, Kanungo SK, Ravi Kumar BVV. RP-HPLC Method for the Estimation of Nebivolol in Tablet Dosage Form. E-Journal of Chem. 2009; 6: 915-919.
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14. Damle MC, Dangi MC, Chaudhari DC, Sinker MC, Racha VC. Stability Indicating HPTLC Method for estimation of Nebivolol hydrochloride and Amlodipine besylate in combination. Eur. J of Anal. Chem. 2010; 5.
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18. Chouhan KS, Bhure MV, Hemke AT, Gupta KR, Wadodkar SG. Development of RP-HPLC method for estimation of Hydrochlorothiazide and Olmesartan Medoxomil in Pharmaceutical Formulation. Res. J Pharma. Biol. Chem. Sci. 2010; 1:78 -84.
19. Carlucci G, Palumbo G, Mazzeo P, Quaglia MG. Simultaneous determination of Losartan and Hydrochlorothiazide in tablets by high-performance liquid chromatography. J Pharm. Biomed. Anal. 2000; 23:185- 189.
20. Carlucci G, Carlo DV, Mazzeo P. Simultaneous determination of Valsartan and Hydrochlorothiazide in tablets by high-performance liquid chromatography. Anal. Lett. 2000; 33:2491-2500.
21. Kanumula GV, Bhanu R. Simultaneous determination of Hydrochlorothiazide and Losartan potassium in pharmaceutical dosage by reverse phase high performance liquid chromatography. Indian Drugs. 2000, 37(1), 38-41.
22. Tarte PS, Wate SP, Khedikar PB, Pawnikar GV. Absorption Correction Method for Estimation of Nebivolol and Hydrochlorothiazide in Combined Tablet Dosage Form. Asian J. Research Chem. 2008; 1:74-76.
23. Shah K, Desai TR, Behera A, Pal RS, Girhepunje KM. Development of spectrophotometric methods for estimation of Nebivolol hydrochloride and Hydrochlorothiazide simultaneously, in bulk and tablet dosage form. Res. J Pharma. Biol. Chem. Sci. 2010; 1:451-457.
24. Shah KV, Thumber BL, Desai TR. Simultaneous Estimation of Nebivolol Hydrochloride and Hydrochlorothiazide in Bulk and Tablet Dosage Form by Q-Analysis Method. Int. J Pharma. Sci. Res. 2009; 1:80-85.
25. Tarte PS, Wate SP, Bondre AV, Paunikar GV. Simultaneous determination of Nebivolol and Hydrochlorothiazide in Tablet dosage form by RP-HPLC. Int. J Pharm Tech Res. 2009; 1:720-724.
26. Dhandapani B, Thirumoorthy N, Prakash DJ. Development and Validation for the Simultaneous Quantification of Nebivolol Hydrochloride and Hydrochlorothiazide by UV Spectroscopy, RP-HPLC and HPTLC in Tablets. E-Journal of Chem. 2010; 7: 341-348.
27. Damle MC, Topagi KS, Bothara KG. Development and validation of a stability-indicating HPTLC method for analysis of Nebivolol hydrochloride and Hydrochlorothiazide in the bulk material and in pharmaceutical dosage forms. Acta Chromatographica. 2010; 22: 433-443.
28. ICH Q2B, Validation of Analytical Procedures: Methodology, International Conference on Harmonization, ICH Harmonized Tripartite Guideline, Geneva, Fed. Regist. 1997; 62: 27463.
2. Sweetman SC, Martindale, The Complete Drug Reference, London; Pharmaceutical Press; Division of the Royal Pharmaceutical Society of Great Britain, 2007.
3. Chaudhary AB, Patel RK, Chaudhary SA. Estimation of Valsartan and Nebivolol in pharmaceutical dosage forms by absorption ratio method. Int. J Res. Pharm. Sci. 2010; 1: 108-112.
4. Yilmaz B. Reverse Phase HPLC Method for Determination of Nebivolol in Pharmaceutical Preparations. Int. J of Pharma. Sci. Review and Res. 2012; 1:14-17.
5. Kachhadia PK, Doshi AS, Joshi HS. Development and validation of a stability-indicating column high-performance liquid chromatographic assay method for determination of Nebivolol in tablet formulation. J of AOAC Int. 2008; 91:557-561.
6. Hendrickx J, Bockx M, Zwijsen C, Borgmans C, Mannens G, Meuldermans W, Heykants J. Location of the hydroxyl functions in hydroxylated metabolites of Nebivolol in different animal species and human subjects as determined by online HPLC-diode array detection. J. Chromatogr. 1996; 729:341-354.
7. Sahoo M K, Giri RK, Barik CS, Kanungo SK, Ravi Kumar BVV. RP-HPLC Method for the Estimation of Nebivolol in Tablet Dosage Form. E-Journal of Chem. 2009; 6: 915-919.
8. Gupta Y, Shrivastava A, Duggal D, Patel A, Agrawal S. A new RP-HPLC method for simultaneous estimation of Nebivolol hydrochloride and Hydrochlorthiazide in dosage forms. J of young Pharm. 2009; 1:264-269.
9. Kokil SU, Bhatia MS. Simultaneous Estimation of Nebivolol Hydrochloride and Valsartan using RP HPLC. Indian J Pharm Sci. 2009; 71:111–114.
10. Kokil SU, Bhatia MS. Liquid chromatographic impurity profiling of Nebivolol Hydrochloride from bulk drug. Der Pharma Chemica. 2009; 1:177-187.
11. Ramakrishna NV, Vishwottam KN, Koteshwara M, Manoj S, Santosh M, Varma DP. Rapid quantification of nebivolol in human plasma by liquid chromatography coupled with electrospray ionization tandem mass spectrometry. J Pharm. Biomed. Anal. 2005; 39:1006-13.
12. Sharma A, Patel B, Patel R. Simultaneous Estimation of Nebivolol Hydrochloride and Amlodipine besylate by High Performance Thin Layer Chromatography. Int. J of Pharma. Bio Sci. 2010; 1:339-347.
13. Reddy TS, Devi PS. Validation of a high-performance thin-layer chromatographic method, with densitometric detection, for quantitative analysis of Nebivolol hydrochloride in tablet formulations. J of Planar Chrom. 2007; 20:149-152.
14. Damle MC, Dangi MC, Chaudhari DC, Sinker MC, Racha VC. Stability Indicating HPTLC Method for estimation of Nebivolol hydrochloride and Amlodipine besylate in combination. Eur. J of Anal. Chem. 2010; 5.
15. Veerasekaran V, Katakdhond SJ, Kadam SS, Rao JR. Simultaneous spectrophotometric estimation of Hydrochlorothiazide and Metoprolol tartrate from combined dosage form. Ind. Drugs. 2001; 38:187-189.
16. Moussa BA, Kousy EL. Colorimetric analysis of some diuretic drugs: hydrochlorothiazide and spironolactone. Pharm. week. Bl. Sci. 1985; 7:79.
17. Hemke AT, Bhure MV, Chouhan KS, Gupta KR, Wadodkar SG. UV Spectrophotometric Determination of Hydrochlorothiazide and Olmesartan Medoxomil in Pharmaceutical Formulation. E-Journal of Chem. 2010; 7:1156-1161.
18. Chouhan KS, Bhure MV, Hemke AT, Gupta KR, Wadodkar SG. Development of RP-HPLC method for estimation of Hydrochlorothiazide and Olmesartan Medoxomil in Pharmaceutical Formulation. Res. J Pharma. Biol. Chem. Sci. 2010; 1:78 -84.
19. Carlucci G, Palumbo G, Mazzeo P, Quaglia MG. Simultaneous determination of Losartan and Hydrochlorothiazide in tablets by high-performance liquid chromatography. J Pharm. Biomed. Anal. 2000; 23:185- 189.
20. Carlucci G, Carlo DV, Mazzeo P. Simultaneous determination of Valsartan and Hydrochlorothiazide in tablets by high-performance liquid chromatography. Anal. Lett. 2000; 33:2491-2500.
21. Kanumula GV, Bhanu R. Simultaneous determination of Hydrochlorothiazide and Losartan potassium in pharmaceutical dosage by reverse phase high performance liquid chromatography. Indian Drugs. 2000, 37(1), 38-41.
22. Tarte PS, Wate SP, Khedikar PB, Pawnikar GV. Absorption Correction Method for Estimation of Nebivolol and Hydrochlorothiazide in Combined Tablet Dosage Form. Asian J. Research Chem. 2008; 1:74-76.
23. Shah K, Desai TR, Behera A, Pal RS, Girhepunje KM. Development of spectrophotometric methods for estimation of Nebivolol hydrochloride and Hydrochlorothiazide simultaneously, in bulk and tablet dosage form. Res. J Pharma. Biol. Chem. Sci. 2010; 1:451-457.
24. Shah KV, Thumber BL, Desai TR. Simultaneous Estimation of Nebivolol Hydrochloride and Hydrochlorothiazide in Bulk and Tablet Dosage Form by Q-Analysis Method. Int. J Pharma. Sci. Res. 2009; 1:80-85.
25. Tarte PS, Wate SP, Bondre AV, Paunikar GV. Simultaneous determination of Nebivolol and Hydrochlorothiazide in Tablet dosage form by RP-HPLC. Int. J Pharm Tech Res. 2009; 1:720-724.
26. Dhandapani B, Thirumoorthy N, Prakash DJ. Development and Validation for the Simultaneous Quantification of Nebivolol Hydrochloride and Hydrochlorothiazide by UV Spectroscopy, RP-HPLC and HPTLC in Tablets. E-Journal of Chem. 2010; 7: 341-348.
27. Damle MC, Topagi KS, Bothara KG. Development and validation of a stability-indicating HPTLC method for analysis of Nebivolol hydrochloride and Hydrochlorothiazide in the bulk material and in pharmaceutical dosage forms. Acta Chromatographica. 2010; 22: 433-443.
28. ICH Q2B, Validation of Analytical Procedures: Methodology, International Conference on Harmonization, ICH Harmonized Tripartite Guideline, Geneva, Fed. Regist. 1997; 62: 27463.
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01-01-2011
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“A VALIDATED HPTLC METHOD FOR SIMULTANEOUS QUANTIFICATION OF NEBIVOLOL AND HYDROCHLOROTHIAZIDE IN BULK AND TABLET FORMULATION”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 3, no. 1, Jan. 2011, pp. 62-66, https://doi.org/10.25004/IJPSDR.2011.030115.
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How to Cite
“A VALIDATED HPTLC METHOD FOR SIMULTANEOUS QUANTIFICATION OF NEBIVOLOL AND HYDROCHLOROTHIAZIDE IN BULK AND TABLET FORMULATION”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 3, no. 1, Jan. 2011, pp. 62-66, https://doi.org/10.25004/IJPSDR.2011.030115.
