DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF TELMISARTAN AND CILNIDIPINE IN COMBINED TABLET DOSAGE FORM
Abstract
A new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for simultaneous estimation of Telmisartan and Cilnidipine in combined tablet dosage form. The mobile phase selected was Toluene: Methanol: Glacial acetic acid (8: 2: 1, v/v/v) with UV detection at 260 nm. The retention factor for Telmisartan and Cilnidipine were found to be 0.38 ± 0.004 and 0.62 ± 0.007. The method was validated with respect to linearity, accuracy, precision and robustness. The drugs were subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Results found to be linear in the concentration range of 200-1400ng band-1 and 50-600ng band-1 for Telmisartan and Cilnidipine, respectively. The method has been successfully applied for the analysis of drugs in pharmaceutical formulation. The % assay (Mean ± S.D.) was found to be 100.79 ± 1.38 for Telmisartan and 99.55 ± 1.13 for Cilnidipine. The developed and validated stability indicating method can be used for assessing the stability of Telmisartan and Cilnidipine in bulk drug and pharmaceutical dosage form.
Keywords:
Telmisartan, Cilnidipine, Forced degradation, Validation, Tablet Dosage FormDOI
https://doi.org/10.25004/IJPSDR.2015.070607References
1. http://en.wikipedia.org/wiki/Telmisartan (accessesed on 20/03/2015)
2. http://en.wikipedia.org/wiki/Cilnidipine (accessesed on 20/03/2015)
3. Patel BA, Captain AD. Development and validation of RP-HPLC method for estimation of telmisartan in bulk and formulation using fluorescence detector. J Biomed Pharma Res. 2014; 3:44-48.
4. Seshagiri Rao JVLN, Vemula Vijayasree V, Palavan C. A validated RP-HPLC method for the estimation of telmisartan in tablet dosage forms. Am. J. PharmTech. Res. 2013; 3:764-769.
5. Vijay Kumar G, Murthy TEGK, Sambasiva Rao KRS. Validated RP-HPLC method for estimation of telmisartan in serum samples. Int. J. Res. Pharm. Chem. 2011, 1:703-706.
6. Rajitha S, Biswal BV, Nagarjuna Reddy DN, Ramesh B. Method development and validation of telmisartan and amlodipine besylate by RP-HPLC in tablet dosage form. Int. J. Pharma Sci. 2013; 3:365-369.
7. Sravani T, Asha Madhuri D, Sirresha D, Akiful Haque M, Padmanabha Rao A, Bakshi V. Development and validation of analytical method for simultaneous estimation of telmisartan and atorvastatin in pharmaceutical formulation by RP-HPLC. IJIPSR. 2014; 2:2980-2987.
8. RLC Sasidhar RLC, Vidyadhara S, Deepti B, Tejaswi K, Suhasini J. Development and validation of RP - HPLC method for the simultaneous determination of hydrochlorothiazide, amlodipine besylate and telmisartan in bulk and pharmaceutical formulation. Oriental J. Chem. 2014; 30:1815-1822.
9. Rajeswari A, Vasanth PM, Ramesh T, Ramesh M. RP-HPLC method development and validation for simultaneous estimation of amlodipine besylate and telmisartan in tablet dosage form. Int. J. Pharm. Res. Anal. 2013; 3:13-17.
10. Navaneetha S, Srinivas M. RP-HPLC Method for the simultaneous estimation of metformin hydrochloride and telmisartan in bulk and in a synthetic mixture. Int J ChemTech Res.2014; 6:4737-4745.
11. Dhanashri S, Rane DS, Chaskar PK, Doshi GM, Mulgund SV, Jain KS. Development and validation of stability indicating RP-HPLC method for simultaneous determination of telmisartan and hydrochlorothiazide from their combination drug product. Der Pharmacia Lettre. 2013; 5:127-134.
12. Santoshkumar M, Venkateshwar Rao J. Development and validation of stability indicating RP-HPLC method for simultaneous determination of telmisartan and amlodipine in combined dosage form. Asian J Pharm Clin Res. 2014; 7:32-35.
13. Ravi VB, Inamadugu JK, Nageswara Rao P, Sreenivasulu V, Ponneri V. Simultaneous determination of telmisartan and amlodipine in human plasma by LC–MS/MS and its application in a human pharmacokinetic study. J Pharm Anal. 2012; 2:319–326.
14. Ilango K, Shiji Kumar PS. Development and validation of stability indicating HPTLC and HPLC methods for simultaneous determination of telmisartan and atorvastatin in their formulations. Journal of Chemistry. 2013;1-9.
15. Jaithlia R, Chouhan R, Chouhan C, Gupta A, Nagori BP. Development of UV spectrophotometer method and its validation for estimation of telmisartan as API and in pharmaceutical dosage form. IJRAP. 2011; 2:1816-1818.
16. Kadam A, Hamrapurkar P, Patil S, Manoharan M, Suryagandha A. Development and validation of stability indicating RP-HPLC method for the estimation of cilnidipine in bulk and pharmaceutical dosage form. Int. J. Pharm. Sci. Rev. Res. 2015; 30:177-181.
17. Kudumula N, Prasad YR. Development and validation of RP-HPLC method for simultaneous estimation of chlorthalidone and cilnidipine in bulk and combined tablet dosage form. Pharmacophore. 2014; 5:442-450.
18. Manzoor A, Rashmi DR, Shetty AS, Anil Kumar SM, Ravi MC, Kuppast IJ. RP-HPLC method development and validation for simultaneous estimation of cilnidipine and olmesartan medoxomil in combined tablet dosage form. World J Pharm Pharm. Sci. 2015; 4:785-795.
19. Saravanan G, Praveen PN, Janeyulu IS, Visagaperumal D. Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of metoprolol succinate and cilnidipine in bulk and pharmaceutical dosage form. Int J Pharm Pharm Sci. 2015; 7:150-154.
20. Minase AS, Dole MN. Development and validation of analytical method for the simultaneous estimation of cilnidipine and olmesartan medoxomil in bulk and tablet dosage form by HPTLC. J Adv Sci Res. 2014; 5:34-38.
21. Soni V, Kakadiya J, Patel P, Shah N. Development and validation of high performance thin layer chromatographic method for cilnidipine and metoprolol succinate in their combined pharmaceutical dosage form. International Journal of Research in Pharmaceutical and Nano Sciences. 2014; 3:61-72.
22. Kadia TK, Shah DB, Dilip GM. Development and validation of Q-absorbance ratio spectrophotometric method for simultaneous estimation of cilnidipine and metoprolol succinate in bulk and combined dosage form. Int J Pharm Pharm Sci. 2014; 6:401-407.
23. Pawar P, Gandhi SV, Deshpande PB, Vanjari S, Shelar SU. Simultaneous RP-HPLC estimation of cilnidipine and telmisartan in combined tablet dosage form. Der Chemica Sinica. 2013; 4:6-10.
24. Haripriya M, Jayasekhar P. Quantitative analysis of cilnidipine and telmisartan in tablets by high performance thin layer chromatography with ultraviolet absorption densitometric detection. 2013; 4:1123-1130.
25. Vahora S, Mehta F, Chhalotiya U, Shah D. Dual wavelength spectrophotometric method for estimation of cilnidipine and telmisartan in their combined dosage form. RRJPA. 2014; 3:22-29.
26. International Conference on Harmonization (2005) ICH harmonised tripartite guideline Validation of analytical procedures: text and methodology Q2 (R1) ICH, Geneva, Nov (2005).
27. International Conference on Harmonization (ICH), Stability testing of new drug substances and products, Q1A (R2), (2003).
2. http://en.wikipedia.org/wiki/Cilnidipine (accessesed on 20/03/2015)
3. Patel BA, Captain AD. Development and validation of RP-HPLC method for estimation of telmisartan in bulk and formulation using fluorescence detector. J Biomed Pharma Res. 2014; 3:44-48.
4. Seshagiri Rao JVLN, Vemula Vijayasree V, Palavan C. A validated RP-HPLC method for the estimation of telmisartan in tablet dosage forms. Am. J. PharmTech. Res. 2013; 3:764-769.
5. Vijay Kumar G, Murthy TEGK, Sambasiva Rao KRS. Validated RP-HPLC method for estimation of telmisartan in serum samples. Int. J. Res. Pharm. Chem. 2011, 1:703-706.
6. Rajitha S, Biswal BV, Nagarjuna Reddy DN, Ramesh B. Method development and validation of telmisartan and amlodipine besylate by RP-HPLC in tablet dosage form. Int. J. Pharma Sci. 2013; 3:365-369.
7. Sravani T, Asha Madhuri D, Sirresha D, Akiful Haque M, Padmanabha Rao A, Bakshi V. Development and validation of analytical method for simultaneous estimation of telmisartan and atorvastatin in pharmaceutical formulation by RP-HPLC. IJIPSR. 2014; 2:2980-2987.
8. RLC Sasidhar RLC, Vidyadhara S, Deepti B, Tejaswi K, Suhasini J. Development and validation of RP - HPLC method for the simultaneous determination of hydrochlorothiazide, amlodipine besylate and telmisartan in bulk and pharmaceutical formulation. Oriental J. Chem. 2014; 30:1815-1822.
9. Rajeswari A, Vasanth PM, Ramesh T, Ramesh M. RP-HPLC method development and validation for simultaneous estimation of amlodipine besylate and telmisartan in tablet dosage form. Int. J. Pharm. Res. Anal. 2013; 3:13-17.
10. Navaneetha S, Srinivas M. RP-HPLC Method for the simultaneous estimation of metformin hydrochloride and telmisartan in bulk and in a synthetic mixture. Int J ChemTech Res.2014; 6:4737-4745.
11. Dhanashri S, Rane DS, Chaskar PK, Doshi GM, Mulgund SV, Jain KS. Development and validation of stability indicating RP-HPLC method for simultaneous determination of telmisartan and hydrochlorothiazide from their combination drug product. Der Pharmacia Lettre. 2013; 5:127-134.
12. Santoshkumar M, Venkateshwar Rao J. Development and validation of stability indicating RP-HPLC method for simultaneous determination of telmisartan and amlodipine in combined dosage form. Asian J Pharm Clin Res. 2014; 7:32-35.
13. Ravi VB, Inamadugu JK, Nageswara Rao P, Sreenivasulu V, Ponneri V. Simultaneous determination of telmisartan and amlodipine in human plasma by LC–MS/MS and its application in a human pharmacokinetic study. J Pharm Anal. 2012; 2:319–326.
14. Ilango K, Shiji Kumar PS. Development and validation of stability indicating HPTLC and HPLC methods for simultaneous determination of telmisartan and atorvastatin in their formulations. Journal of Chemistry. 2013;1-9.
15. Jaithlia R, Chouhan R, Chouhan C, Gupta A, Nagori BP. Development of UV spectrophotometer method and its validation for estimation of telmisartan as API and in pharmaceutical dosage form. IJRAP. 2011; 2:1816-1818.
16. Kadam A, Hamrapurkar P, Patil S, Manoharan M, Suryagandha A. Development and validation of stability indicating RP-HPLC method for the estimation of cilnidipine in bulk and pharmaceutical dosage form. Int. J. Pharm. Sci. Rev. Res. 2015; 30:177-181.
17. Kudumula N, Prasad YR. Development and validation of RP-HPLC method for simultaneous estimation of chlorthalidone and cilnidipine in bulk and combined tablet dosage form. Pharmacophore. 2014; 5:442-450.
18. Manzoor A, Rashmi DR, Shetty AS, Anil Kumar SM, Ravi MC, Kuppast IJ. RP-HPLC method development and validation for simultaneous estimation of cilnidipine and olmesartan medoxomil in combined tablet dosage form. World J Pharm Pharm. Sci. 2015; 4:785-795.
19. Saravanan G, Praveen PN, Janeyulu IS, Visagaperumal D. Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of metoprolol succinate and cilnidipine in bulk and pharmaceutical dosage form. Int J Pharm Pharm Sci. 2015; 7:150-154.
20. Minase AS, Dole MN. Development and validation of analytical method for the simultaneous estimation of cilnidipine and olmesartan medoxomil in bulk and tablet dosage form by HPTLC. J Adv Sci Res. 2014; 5:34-38.
21. Soni V, Kakadiya J, Patel P, Shah N. Development and validation of high performance thin layer chromatographic method for cilnidipine and metoprolol succinate in their combined pharmaceutical dosage form. International Journal of Research in Pharmaceutical and Nano Sciences. 2014; 3:61-72.
22. Kadia TK, Shah DB, Dilip GM. Development and validation of Q-absorbance ratio spectrophotometric method for simultaneous estimation of cilnidipine and metoprolol succinate in bulk and combined dosage form. Int J Pharm Pharm Sci. 2014; 6:401-407.
23. Pawar P, Gandhi SV, Deshpande PB, Vanjari S, Shelar SU. Simultaneous RP-HPLC estimation of cilnidipine and telmisartan in combined tablet dosage form. Der Chemica Sinica. 2013; 4:6-10.
24. Haripriya M, Jayasekhar P. Quantitative analysis of cilnidipine and telmisartan in tablets by high performance thin layer chromatography with ultraviolet absorption densitometric detection. 2013; 4:1123-1130.
25. Vahora S, Mehta F, Chhalotiya U, Shah D. Dual wavelength spectrophotometric method for estimation of cilnidipine and telmisartan in their combined dosage form. RRJPA. 2014; 3:22-29.
26. International Conference on Harmonization (2005) ICH harmonised tripartite guideline Validation of analytical procedures: text and methodology Q2 (R1) ICH, Geneva, Nov (2005).
27. International Conference on Harmonization (ICH), Stability testing of new drug substances and products, Q1A (R2), (2003).
Published
01-11-2015
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“DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF TELMISARTAN AND CILNIDIPINE IN COMBINED TABLET DOSAGE FORM”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 7, no. 6, Nov. 2015, pp. 478-83, https://doi.org/10.25004/IJPSDR.2015.070607.
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How to Cite
“DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF TELMISARTAN AND CILNIDIPINE IN COMBINED TABLET DOSAGE FORM”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 7, no. 6, Nov. 2015, pp. 478-83, https://doi.org/10.25004/IJPSDR.2015.070607.
