Stability-indicating method for the determination of assay and quantification of impurities in amlodipine–atorvastatin combination dosage form by RP-HPLC

References

• Shah, D. A.; Bhatt, K. K.; Mehta, R. S.; Baldania, S. L. Stability Indicating RP-HPLC Estimation of Atorvastatin Calcium and Amlodipine Besylate in Pharmaceutical Formulations. Indian J. Pharm. Sci. 2008, 70(6), 754–760.
   PubMed Web of Science ®Google Scholar
• Vadlamudi, M. K.; Dhanaraj, S.; Yarkala, S.; Jayapal, J. J.; Kommavarapu, P. K. Development of Stability Indicating RP-HPLC Method for the Determination of Related Substances in Atorvastatin Solid Dosage Form and Bulk Drugs. Int. J. Pharm. Pharm. Sci. 2015, 7(12), 184–194.
   Google Scholar
• Ertürk, S.; Aktaş, E. S.; Ersoy, L.; Fıçıcıoğlu, S. An HPLC Method for the Determination of Atorvastatin and its Impurities in Bulk Drug and Tablets. J. Pharm. Biomed. Anal. 2003, 33(5), 1017–1023.
   PubMed Web of Science ®Google Scholar
• Nataraj, K. S.; Alekhya, K.; Surendra, B. B.; Gnananath, K.; Bindu, C. Analytical Method Development and Validation of Simultaneous Estimation of Amlodipine Besylate and Atorvastatin Calcium by RP-HPLC Method. J. Chem. Pharm. Res. 2015, 7, 35–41.
   Google Scholar
• Juyal, V.; Chaudhary, M.; Kumar, P.; Gnanarajan, G.; Yadav, P. K. Method Development and its Validation for Simultaneous Estimation of Atorvastatin and Amlodipine in Combination in Tablet Dosage Form by UV Spectroscopy, Using Multi-Component Mode of Analysis. J. Pharm. Res. 2008, 1(2), 182–187.
   Google Scholar
• Moussa, B. A.; El-Zaher, A. A.; Mahrouse, M. A.; Ahmed, M. S. Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium in Binary Mixture by Spectrofluorimetry and HPLC Coupled with Fluorescence Detection. Anal. Chem. Insights 2013, 8, 107–115.
   PubMedGoogle Scholar
• Venkata Eranki, R. J.; Inti, G.; Jayaraman, V.; Vidiyala, S. R.; SreeRamulu, J. New Stability Indicating Method for Quantification of Impurities in Amlodipine and Valsartan Tablets by Validated HPLC. ISRN Med. Chem. 2013, 2013, Article ID 178269, 9 pages.
   Google Scholar
• Abdel-Hay, M. H. Stability-Indicating Derivative Spectrophotometric Determination of Frusemide. Int. J. Pharm. 1993, 99(2–3), 333–336.
   Web of Science ®Google Scholar
• Abdallah, O. M.; Badawey, A. M. Derivative Ratio Spectrophotometric, Chemometric and HPLC Validated Methods for Simultaneous Determination of Amlodipine and Atorvastatin in Combined Dosage Form. Int. J. Ind. Chem. 2011, 2(2), 78–85.
   Google Scholar
• Mckeage, K.; Siddiqui, M.; Asif, A. A Review of its Use in the Prevention of Cardiovascular Disease and in the Treatment of Hypertension and Dyslipidemia. Am. J. Cardiovasc. Drugs 2008, 8, 51–67.
   PubMed Web of Science ®Google Scholar
• Danafar, H.; Hamidi, M. Pharmacokinetics and Bioequivalence Study of Amlodipine and Atorvastatin in Healthy Male Volunteers by LCMS. Pharm. Sci. 2015, 21(Suppl 1), 167–174.
   Google Scholar
• Ibrahim, N. O. H. A.; Rizk, M. O. H. A. M. E. D.; Ibrahim, A. H. M. E. D.; Tawakkol, S. H. E. R. E. E. N.; Ali, I. N. A. S. Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium by Using Spectrophotometric Method with Multivariate Calibration and HPLC Method Implementing “Design of Experiment”. Int. J. Pharm. Pharm. Sci. 2014, 6(1), 419–425.
   Google Scholar
• Muthu, A. K.; Gupta, T. R.; Sharma, S.; Smith, A. A.; Manavalan, R.; Kannappan, N. Simultaneous Estimation of Amlodipine and Atorvastatin in Tablets Using Orthogonal Function Ratio Spectrometry. Int. J. Chem. Sci. 2008, 6(4), 2233–2241.
   Google Scholar
• Darwish, H. W.; Hassan, S. A.; Salem, M. Y.; El-Zeany, B. A. Development and Validation of H-Point Standard Addition Method Applied for the Analysis of Binary Mixture of Amlodipine and Atorvastatin. Int. J. Pharm. Bio Sci. 2013, 4(2), 230–243.
   Google Scholar
• Monograph US. Amlodipine, Atorvastatin. InUSP38-NF33, The United States Pharmacopeia Convention, official August 2017.
   Google Scholar
• Ramesh, D.; Ramakrishna, S. New Spectrophotometric Methods for Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium in Tablet Dosage Forms. Int. J. Pharm. Pharm. Sci. 2010, 2, 215–219.
   Google Scholar
• Sharma, K.; Sharma, Y.; Sharma, P. Validated Method Development for Estimation of Atorvastatin and Amlodipine in Solid Dosage Regimens. 2013, 2, 344–348.
   Google Scholar
• Sharma, A. K.; Dharamsi, A. Development and Validation of RP-HPLC and Spectrophotometric Method for Simultaneous Estimation of Atorvastatin and Amlodipine in Pharmaceutical Dosage Forms. Int. J. Pharm. Sci. Res. 2012, 3(4), 1202–1207.
   Google Scholar
• Acharjya, S. K.; Annapurna, M. M.; Koya, S. Liquid Chromatographic Method for Simultaneous Estimation of Atorvastatin Calcium and Amlodipine Besylate in Pharmaceutical Dosage Forms. Int. J. Pharm. Bio Sci. 2010, 1, 161–170.
   Google Scholar
• Milind, U. RP-HPLC Method for Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium: Application to Commercially Available Drug Products. Int. Arch. Appl. Sci. Technol. 2014, 5, 22–27.
   Google Scholar
• Pathak, A.; Rajput, S. J. Development of a Stability-Indicating HPLC Method for Simultaneous Determination of Olanzapine and Fluoxetine in Combined Dosage Forms. J. Chromatogr. Sci. 2009, 47(7), 605–611.
   PubMed Web of Science ®Google Scholar
• Ahmed, M.; Manohara, Y. N.; Ravi, M. C. RP-HPLC Method Development and Validation for Simultaneous Estimation of Atorvastatin Calcium and Amlodipine Besylate. Int. J. ChemTech Res. 2012, 4, 337–345.
   Google Scholar
• Bharat, G. C.; Ashok, B. P. Simultaneous Spectrophotometric Estimation of Atorvastatin Calcium and Amlodipine Besylate in Tablet Dosage Forms. Int. J. ChemTech Res. 2010, 2, 633–639.
   Google Scholar
• Hafez, H. M.; Elshanawany, A. A.; Abdelaziz, L. M.; Mohram, M. S. Development of a Stability-Indicating HPLC Method for Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium in Tablets. Austin J. Anal. Pharm. Chem. 2014, 1(6), 1028.
   Google Scholar
• Vidyadhara, S.; Sasidhar, R. L. C.; Satyaprasanna, P.; Ch, A. K.; Aruna, K. G. RP-HPLC Method Development for the Simultaneous Estimation of Atorvastatin and Amlodipine Besylate in Bulk and Pharmaceutical Dosage Forms. Pelagia Res. Library 2015, 6(10), 1–10.
   Google Scholar
• Freddy, H.; Chaudhari, V. Simultaneous Determination of Atorvastatin Calcium and Amlodipine Besylate from Pharmaceutical Formulation by Reversed Phase High Performance Liquid Chromatography. Asian J. Chem. 2005, 17(4), 2502–2508.
   Google Scholar
• Eranki, R. J. V.; Inti, G.; Jayaraman, V.; Pannala, R.; Vidiyala, S. R.; Ramulu, J. S. New Stability Indicating a Method for Quantification of Impurities in Amlodipine and Atorvastatin Calcium Tablets by Validated HPLC. Int. J. Pharm. Res. Scholars 2013, 2, 458–471.
   Google Scholar
• Mohammadi, A.; Rezanour, N.; Dogaheh, M. A.; Bidkorbeh, F. G.; Hashem, M.; Walker, R. B. A Stability-Indicating High Performance Liquid Chromatographic (HPLC) Assay for the Simultaneous Determination of Atorvastatin and Amlodipine in Commercial Tablets. J. Chromatogr. B 2007, 846(1), 215–221.
   PubMed Web of Science ®Google Scholar
• ICH, Validation of Analytical Procedures: Methodology, Proceeding of the International Conference on Harmonization, Geneva, 6 November 1996.
   Google Scholar
• Blessy, M. R.; Patel, R. D.; Prajapati, P. N.; Agrawal, Y. K. Development of Forced Degradation and Stability Indicating Studies of Drugs—A Review. J. Pharm. Anal. 2014, 4, 159–165.
   PubMedGoogle Scholar
• Singh, S.; Junwal, M.; Modhe, G.; Tiwari, H.; Kurmi, M.; Parashar, N.; Sidduri, P. Forced Degradation Studies to Assess the Stability of Drugs and Products. TrAC Trends Anal. Chem. 2013, 49, 71–88.
   Web of Science ®Google Scholar