Method Development and Validation for the Determination of Potential Impurities Present in Olmesartan Medoxomil and Hydrochlorothiazide in Fixed Dose Combination Drug Product by Using Reverse Phase – Ultra-Performance Liquid Chromatography Coupled with Diode-Array Detector

References

• Liu, Dong-yang; Jiang, Ji; Wang, Chen-guang; Zhang, Jian-yan; Hu, Pei. Pharmacokinetics and Tolerability of Olmesartan Medoxomil Plus Hydrochlorothiazide Combination in Healthy Chinese Subjects: Drug-Drug Interaction, Bioequivalence, and Accumulation. Int. J. Clin. Pharmacol. Therapeut. 2014, 52 (4), 321–327.
   PubMed Web of Science ®Google Scholar
• Wan, Qian; Huang, Yuan-yuan; Fu, Zhi-min; Tan, Hong-yi; Pei, Qi; Huang, Zhi-jun; Yang, Guo-ping. Pharmacokinetics of Compound Olmesartan Medoxomil and Hydrochlorothiazide Tablets in Chinese Healthy Volunteers. Zhongguo Linchuang Yaolixue Yu Zhiliaoxue 2011, 16 (4), 393–399.
   Google Scholar
• Kumari, Babita; Burande, Mahesh D.; Choudhari, Prashant K. Spectrophotometric Method for Simultaneous Estimation of Olmesartan Medoxomil and Hydrochlorothiazide in Tablets. Res. J. Pharmaceut., Biol. Chem. Sci. 2013, 4 (2), 104–109.
   Google Scholar
• Rote, A. R.; Bari, P. D. Spectrophotometric Estimation of Olmesartan Medoxomil and Hydrochlorothiazide in Tablet. Indian J. Pharmaceut. Sci. 2010, 72 (1), 111–113.
   PubMed Web of Science ®Google Scholar
• Merey, Hanan A.; Ramadan, Nesrin K.; Diab, Sherine S.; Moustafa, Azza A. Spectrophotometric methods for simultaneous determination of ternary mixture of amlodipine besylate, Olmesartan medoxomil and hydrochlorothiazide. Spectrochim. Acta, Part A: Mol. Biomol. Spectrosc. 2014, 125, 138–146.
   PubMed Web of Science ®Google Scholar
• Sharma, Hemendra Kumar; Jain, Nilesh; Jain, Surendra Kumar. Development of Spectrophotometric Method for Quantitative Estimation of Amlodipine Besylate, Olmesartan Medoxomil and Hydrochlorthiazide in Tablet Dosage Form. Pharmaceut. Anal. Acta 2011, 2 (4), 126.
   Google Scholar
• Delhiraj, N.; Baksh, Alla; Parveen, Azra; Tahimeen; Khan, Muzzamil; Anbazhagan, S. Simultaneous Spectrophotometric Estimation of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide in Pharmaceutical Dosage Form. J. Chem. Pharmaceut. Sci. 2012, 5 (1), 30–32, 3 pp.
   Google Scholar
• Patel, Samixa R.; Patel, Chhaganbhai N. Development and Validation of Spectrophotometric Method for Determination of Olmesartan, Amlodipine and Hydrochlorothiazide in Combined Pharmaceutical Dosage Forms. Novel Sci. Int. J. Pharmaceut. Sci. 2012, 1 (6), 317–321.
   Google Scholar
• Ilango, Kaliappan; Shiji Kumar, Pushpangadhan S. Application of a Stability-Indicating HPTLC Method for Simultaneous Quantitative Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Pharmaceutical Dosage Forms. J. Anal. Methods Chem. 2013, 363741, 9 pp.
   Google Scholar
• Kadukar, Sayali S.; Gandhi, Santosh V.; Ranjane, Poonam N.; Ranher, Sandeep S. HPTLC Analysis of Olmesartan Medoxomil and Hydrochlorothiazide in Combination Tablet Dosage Forms. J. Planar Chromatogr. – Mod. TLC 2009, 22 (6), 425–428.
   Web of Science ®Google Scholar
• Moussa, Bahia; Mohamed, Marwa; Youssef, Nadia. Simultaneous Densitometric TLC Analysis of Olmesartan Medoxomil and Hydrochlorothiazide in the Tablet Dosage Form. J. Planar Chromatogr. – Mod. TLC 2011, 24 (1), 35–39
   Web of Science ®Google Scholar
• Ilango Kaliappan; Shiji Kumar Pushpangadhan S. Application of a Stability-Indicating HPTLC Method for Simultaneous Quantitative Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Pharmaceutical Dosage Forms. J. Anal. Methods Chem. 2013, 2013363741.
   Google Scholar
• Dubey, Nitin; Jain, Ankit; Raghuwanshi, Ajay Kumar; Jain, Dinesh Kumar. Stability-Indicating HPTLC Method for Simultaneous Estimation of Amlodipine Besylate, Hydrochlorothiazide and Olmesartan Medoxomil in Combined Tablet Dosage Forms. J. Planar Chromatogr. – Mod. TLC 2012, 25 (5), 475–480.
   Web of Science ®Google Scholar
• Chen, Min; Zhou, Bin; Wei, Da-peng. HPLC Determination of Compound Olmesartan Medoxomil-Hydrochlorothiazide Tablets. Zhongguo Xinyao Zazhi 2006, 15 (23), 2050–2052.
   Google Scholar
• Chouhan, K. S.; Bhure, M. V.; Hemke, A. T.; Gupta, K. R.; Wadodkar, S. G. Development of RP-HPLC Method for Estimation of Hydrochlorothiazide and Olmesartan Medoxomil in Pharmaceutical Formulation. Res. J. Pharmaceut., Biol. Chem. Sci. 2010, 1 (2), 78–84.
   Google Scholar
• Kumar, J. Ashok; Sathya, A.; Kumar, K. Senthil; Sagar, Patil N.; Prathap, B.; Lokesh, S. B.; Gopal, V. Simultaneous Estimation of Olmesartan Medoxomil and Hydrochlorothiazide by RP-HPLC Method from Combined Dosage Forms. Int. J. Res. Pharmaceut. Sci. 2010, 1 (1), 24–27.
   Google Scholar
• Prathap, B.; Rajendran, S. S.; Dinakar, A.; Srinivasa, Rao G.; Santosh, K.; Ranajit; Venugopal, V. Analytical Method Development and Validation for the Simultaneous Estimation of Olmesartan Medoxomil and Hydrochlorothiazide in Combined Tablet Dosage Form by Rp-hplc. J. Pharm. Chem. 2010, 4 (3), 71–74
   Google Scholar
• Rai, Megha; Kawde, P. B. Simultaneous Determination of Olmesartan, Amlodipine Besylate and Hydrochlorothiazide in Tablet Dosage Form by Using Stability-Indicating HPLC Method. Res. J. Pharmaceut., Biol. Chem. Sci. 2013, 4 (1), 560–567
   Google Scholar
• Bari, P. D.; Rote, A. R. RP-LC and HPTLC Methods for the Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Combined Tablet Dosage Forms. Chromatographia 2009, 69 (11/12), 1469–1472.
   PubMed Web of Science ®Google Scholar
• Rao, Janhavi R.; Rajput, Milindkumar P.; Yadav, Savita S.; Mulla, Toufik S.; Bharekar, Vishal V. Simultaneous Quantitation of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide in Pharmaceutical Dosage Form by Using HPLC. Int. J. PharmTech Res. 2011, 3 (3), 1435–1440.
   Google Scholar
• Ashutosh Kumar, S.; Debnath, Manidipa; Seshagiri Rao, J. V. L. N.; Gowri Sankar, D. A New and Rapid Analytical Method Development & Validation for Simultaneous Estimation of Hydrochlorothiazide, Amlodipine & Olmesartan in Tablet Dosage Form by Using RP-HPLC. J. Chem. Pharmaceut. Res. 2014, 6 (5), 1208–1213, 6 pp.
   Google Scholar
• Pandya, Gaurang P.; Joshi, Hitendra S. Development and Validation of Stability Indicating HPLC Assay Method for Simultaneous Determination of Amlodipine Besylate, Olmesartan Medoxomil and Hydrochlorothiazide in Tablet Formulation. Pharm. Sin. 2013, 4 (2), 145–152.
   Google Scholar
• Nalluri, Buchi N.; Venkateswara Naik, D.; Sunandana, B.; Sushmitha, K. Development and Validation of RP-HPLC-PDA Method for the Simultaneous Estimation of Hydrochlorothiazide, Amlodipine Besylate and Olmesartan Medoxomil in Bulk and Pharmaceutical Dosage Forms. J. Chem. Pharmaceut. Res. 2013, 5 (1), 329–335.
   Google Scholar
• Dubey, Nitin; Jain, Ankit; Raghuwanshi, Ajay K.; Jain, Dinesh K. Simultaneous Determination and Validation of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide in Combined Tablet Dosage Form Using RP-HPLC Method. Asian J. Chem. 2012, 24 (10), 4535–4537.
   Web of Science ®Google Scholar
• Zhao, Jianfeng. Determination of the Content and Related Substances of Olmesartan Medoxomil/Hydrochlorothiazide Tablets by HPLC. Zhongguo Zhiye Yaoshi 2012, 9 (7), 23–25.
   Google Scholar
• ICH. Validation of Analytical Procedures: Text and Methodology, Q2 (R1), 2005.
   Google Scholar
• ICH. Stability Testing of New Drug Substances and Products, Q1A (R2), 2005.
   Google Scholar
• US FDA Guidance. Analytical Procedures and Methods Validation, 2000.
   Google Scholar
• Official Methods of Analysis, 15th ed., Association of Official Analytical Chemists International, Arlington, VA, 1990; XVII.
   Google Scholar
• Validation of Compendial Methods <1225> The United States Pharmacopeia, 2012.
   Google Scholar
• United States Pharmacopeial Convention, 36th ed.; The United States Pharmacopoeia, Rockville, MD, 2012.
   Google Scholar
• Guideline for Submitting Samples and Analytical Data for Methods Validation. US Food and Drug Administration, February 1987.
   Google Scholar
• Bliesner, D. M. Validating Chromatographic Methods: A Practical Guide; John Wiley & Sons, Inc., Hoboken, New Jersey, 2006.
   Google Scholar
• Baertschi, S. W.; Alsante, K.; Reed, R. A. Pharmaceutical Stress Testing: Predicting Drug Degradation; Informa Healthcare, Telephone House, London, 2005.
   Google Scholar