Development and Validation of Method for the Estimation of Telmisartan as Active Pharmaceutical Ingredient in Tablet Dosage form and Prepared Spherical Agglomerates by RP-HPLC

Published: May 7, 2016

Authors

  • Sharma Shaina Khalsa College of Pharmacy, Amritsar, Punjab, India
  • Soni Varinder Khalsa College of Pharmacy, Amritsar, Punjab, India
  • Rahar Sandeep Khalsa College of Pharmacy, Amritsar, Punjab, India
  • Bhatia Nitish Khalsa College of Pharmacy, Amritsar, Punjab, India
Keywords
RP HPLC, Method Development, Telmisartan, tablet, Spherical agglomerates, Validation

Abstract

The Present work was designed to develop and validate an accurate, precise and rapid method for the estimation of Telmisartan as Active Pharmaceutical Ingredient (API) as well as in tablet dosage form and prepared spherical agglomerates by RP-HPLC. The developed method was found to be simple, accurate, precise and sensitive. The separation was achieved on an Isocratic High Pressure Liquid Chromatography (HPLC) (Thermo Scientific) using pumps Jasco PU 2080 Plus, UV detector, column oven (Jasco), and a Reverse Phase C-18 (phenyl) Column (25 cm x 4.6 mm) i.d., particle size 5 μm. The HPLC system was run with flow rate: 0.8 ml/min Injection Volume: 10μl and run time: 10 min, Detector temp: 40 oC. The method was validated for specificity, precision, linearity, and accuracy, robustness, LOD and LOQ parameters. The recovery range was within the range of 99.0–102.0% and the method could be successfully applied for the routine analysis of the drug substance as well as the spherical agglomerates prepared by crystallo coagglomeration technique.

References

  • A.R. Chabukswar, S.C. Jagdale, S.V. Kumbhar, et al. (2010). Simultaneous HPTLC estimation of telmisartan and amlodipine besylate in tablet dosage form. Arch Applied Sci Res, 2(3), 94–100.
  • Ajit Pandey, H.Sawarkar, Mukesh Singh, Dr. P Kashyap, Priyanka Ghosh, (2011). UV Spectrophotometric Method for estimation of Telmisartan in Bulk and Tablet Dosage Form. Int. J. ChemTech. Res, 3(2), 657–660.
  • Benson, S.C., Pershadsingh, H.; Ho, C., Chittiboyina, A., Desai, P., Pravenec, M., Qi, N., Wang, J. et al. (2004).Identification of Telmisartan as a Unique Angiotensin II Receptor Antagonist with Selective PPAR -Modulating Activity. Hypertension, 43(5), 993. http://dx.doi.org/10.1161/01.HYP.0000123072.34629.57
  • C. D. Niranjan, S. M. Patil, J. K. Sabaji, and A. N. Chivate. (2012). “Development of UV spectrophotometric method for estimation and validation of telmisartan as a pure API”. J. Pharm. Res, 5(6), 3331–3333.
  • C. Prabhu, G.S. Subramanian, A. Karthik, S. Kini, M. S. Rajan, and N. Udupa, et al. (2007). Determination of telmisartan by HPTLC – A stability indicating assay. J Planar Chromatograph—Modern TLC, 20(6), 477–481. http://dx.doi.org/10.1556/JPC.20.2007.6.14
  • Ch. Phani Kishore, V. Bhanuprakash Reddy, Dhanashri M Kale, et al. (2010). Development and validation of stability indicating HPLC method for the estimation of Telmisartan related substances in tablets formulation, Int. J. Res. Pharm. Sci., 1(4), 493–501.
  • G. Vijay Kumar, TEGK. Murthy and KRS. Sambasiva Rao, et al. (2011). Validated RPHPLC method for the estimation of telmisartan in serum samples. Int. J. Res. Pharm and Chem, 1(3), 703–706.
  • Ilingo K, Shiji Kumar PS. (2011). Simultaneous estimation of telmisartan and hydrochlorothiazide in pharmaceutical dosage form. Asian J Pharm Health Sci., 1, 12–15.
  • Jaithlia Rajiv, Chouhan Raj Kumar, Chouhan Chetan, Gupta Aakash, Nagori B.P., et al. (2011). Development of UV spectrophotometric method and its validation for estimation of telmisartan as API and in Pharmaceutical dosage form. Int. J. Res Ayurveda & Pharm, 2(6), 1816–1818.
  • K Narendra kumar reddy, G Devala rao, P Hema pratyusha, et al. (2012). Isocractic RPHPLC method validation of telmisartan in pharmaceutical formulation with stress test stability evaluation of drug substance. J Chem. Pharm Sci, 5(1), 16–21.
  • Kavitha J, Nagarajan JSK, Muralidharan S, Suresh B, Development and validation of RP-HPLC method for simultaneous estimation of telmisartan and hydrochlorthiazide in tablets; its application to routine quality control analysis, Int J Pharm Pharm Sci, 2011.
  • Kondawar MS, Kamble KG, Raut KS, Maharshi KH. (2011). UV spectrophotometric estimation of amlodipine besylate and telmisartan in bulk drug and dosage form by multiwavelength analysis. Int J ChemTech Res, 3, 1274–1278.
  • M.V. Basaveswara Rao, A.V.D. Nagendrakumar, M. Sivanadh, and G. Venkata Rao, Validated rp-hplc method for the estimation of telmisartan in tablet formulation, Bull. Pharm. Res, 2012; 2(2), 50–55.
  • NR Vekariya, GF Patel and Rohit B Dholakiya, et al. (2009). Determination of Telmisartan in Solid Dosage Form by RP-HPLC. Asian J. Res. Chem, 2(4); 1–3.
  • Ontarget, I., Yusuf, S., Teo, K., Pogue, J., Dyal, L., Copland, I., Schumacher, H, Dagenais, G. et al. (2008).Telmisartan, Ramipril, or Both in Patients at High Risk for Vascular Events. New Eng. J. Med., 358 (15), 1547–1559. http://dx.doi.org/10.1056/NEJMoa0801317
  • P. Pawar, S. V. Gandhi, P. B. Deshpande, B. Padmanabh, S. Vanjari, and S. U. Shelar, (2013). Simultaneous RP-HPLC estimation of cilnidipine and telmisartan in combinedtable dosage form.Chemica Sinica, 4(2), 6–10.
  • P. Vani and S. K. Kalyana, et al. (2013).”A rapid stability-indicating simultaneous determenation of hydrochlorothiazide, ramipril and telmisartan in combined dosage form by ultra performance liquid chromatography”. Pharmacia Letter, 5(3), 81–89.
  • Palled MS, Chatter M, Rajesh PM, Bhat AR. (2006).Difference spectrophotometric determination of telmisartan in tablet dosage forms. Indian J Pharm Sci, 68(5), 685–686. http://dx.doi.org/10.4103/0250-474X.29653
  • Patel K, Dhudasia K, Patel A, Dave J, Patel C, et al. (2011). Stess degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dasage forms, Pharm Methods, 2, 253–259. http://dx.doi.org/10.4103/2229-4708.93396
  • Pratap Y. Pawar, Manish A. Raskar, Swati U. Kalure, Reshma B. Kulkarni, Simultaneous spectrophotometric estimation of amlodipine besylate and telmisartan in tablet dosage form, Der Pharmcia Chemica, 2012; 4(2), 725–730.
  • Prentice, A. (1999). Medical Management of Menorrhagia. Brit. Med. J, 319, 1343–1345. http://dx.doi.org/10.1136/bmj.319.7221.1343
  • Rekha Gangola, Narendra Singh, Anand Gaurav, Mukesh Maithani and Ranjit Singh, (2011). Spectrophotometric simultaneous determination of hydrochlorothiazide and telmisartan in combined dosage form by dual wavelength method. Int J Comp Pharm, 2(2), 1–3.
  • Sagar Tatane. (2011). Development of UV spectrophotometric method of telmisartan in tablet formulation, J. adv. Pharm.& healthcare Res, 1, 23–26.
  • Shabir, G.A. (2003). Validation of HPLC Chromatography Methods for Pharmaceutical Analysis‖, Understanding the Differences and Similarities between Validation Requirements of FDA, the US Pharmacopeia and the ICH, J Chromatogr. A, 987(1-2), 57-66. http://dx.doi.org/10.1016/S0021-9673(02)01536-4
  • Shah N.J., Suhagia B.H., Shah R.R. and Shah P.B., et al. (2007). Development and Validation of a HPTLC method for the simultaneous estimation of Telmisartan and Hydrochlorthiazide in tablet dosage form. Indian J Pharm Sci., 69, 202-205. http://dx.doi.org/10.4103/0250-474X.33143
  • Shen J, Jiao Z, Li ZD, Shi XJ, Zhong MK, et al. (2005). HPLC determination of telmisartan in human plasma and its application to a pharmacokinetic study. Phamazie, 60(6), 418–420.
  • Sujana K, Gowri Sankar D, Souri B, Swathi Rani G, Stability indicating RP-HPLC method for the determination of telmisartan in pure and pharmaceutical formulations, Int J Pharm Sci, 2011; 3(1); 164–167.
  • Sunil Jawla, K Jeyalakshmi, T Krishnamurthy, Y. Kumar, (2010). Development and Validation of Simultaneous HPLC method for Estimation of Telmisartan and Ramipril in Pharmaceutical Formulations. Int J Pharm Tech Res, 2(2), 1625–1633.
  • Thomas AB, Jagdale SN, Dighe SB, Nanda RK., et. al. (2010). Simultaneous spectrophotometric estimation of amlodipine besylate and telmisartan in tablet dosage form. Int J Chem Tech Res. 2, 1334–1341.
  • V Kabra, V Agrahari, P Trivedi, et al. (2009). Development and validation of a reverse phase liquid chromatographic method for quantitative estimation of telmisartan in human plasma. Chwee Teck Lim, James C.H. Goh (Eds.), 23, 1297–1300. http://dx.doi.org/10.1007/978-3-540-92841-6_319
  • V. Bhavani, T. Siva Rao, SVN Raju, B. Madhusudan, Jamelunnisa Begum, Stability indicating uplc method for the estimation of telmisartan related substances in tablets formulation, Int J Sci and Res Pub, 2013; 3(2), 1–8.
  • V.A. Patel, P. G. Patel, B. G. Chaudhary, N. B. Rajgor, and S. G. Rathi, et al. (2010). Development and validation of hptlc method for the simultaneous estimation of telmisartan and ramipril in combined dosage form. Int J Pharm and Bio Res, 1(1), 18–24.
  • Vinit Chavhan, Rohini Lawande, Jyoti Salunke, Minal Ghante, Supriya Jagtap. (2013). UV spectrophotometric method development and validation for telmisartan in bulk and tablet dosage form. Asian J Pharm Clin Res, 2013; 6(4), 19–21.
  • Wankhede S.B., Tajne M.R., Gupta K.R. and Wadodkar S.S. et al. (2007). RP-HPLC method for estimation of Telmisartan and Hydrochlorthiazide in tablet dosage form. Ind J Pharm Sci, 69(2), 298-300. http://dx.doi.org/10.4103/0250-474X.33164
  • Wood, C. K. (1996). Medicare Program; Changes to the Hospital Outpatient Prospective. Med. J. Aust, 165, 510–514.

How to Cite

Sharma Shaina, Soni Varinder, Rahar Sandeep, Bhatia Nitish. Development and Validation of Method for the Estimation of Telmisartan as Active Pharmaceutical Ingredient in Tablet Dosage form and Prepared Spherical Agglomerates by RP-HPLC. J. Pharm. Technol. Res. Manag.. 2016, 04, 63-79
Development and Validation of Method for the Estimation of Telmisartan as Active Pharmaceutical Ingredient in Tablet Dosage form and Prepared Spherical Agglomerates by RP-HPLC

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