Quantitative estimation of mebeverine hydrochloride in sustained-release dosage form using an analytical lifecycle management oriented stability-indicating LC method

References

• Life Cycle Management of Analytical Procedures. 2016. Accessed online from: www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/ revisions/lifecycle_pdf.pdf (accessed Feb 11, 2018).
   Google Scholar
• Parr, M. K.; Schmidt, A. H. Life Cycle Management of Analytical Methods. J. Pharm. Biomed. Anal. 2018, 147, 506–517. DOI: 10.1016/j.jpba.2017.06.020.
   PubMed Web of Science ®Google Scholar
• Panda, S. S.; Ravi Kumar, B. V. V.; Patel, P. K.; Panda, J. New RP-UFLC Method for Estimation of Xanthinol Nicotinate in Pharmaceutical Dosage Form. Chem. Sci. Trans. 2013, 2, 656–662. DOI: 10.7598/cst2013.379.
   Google Scholar
• Panda, S. S.; Ravi Kumar, B. V. V.; Mohanta, G.; Panda, J. Reverse Phase Ultra Fast Liquid Chromatography Method for Simultaneous Estimation of Citicoline Sodium and Piracetam in Tablets. Int. J. Pharm. Sci. Nanotech. 2013, 6, 1952–1957.
   Google Scholar
• Panda, S. S.; Ravi Kumar, B. V. V.; Acharjya, S. K.; Sahu, K. RP-UFLC Method for Estimation of Propafenone in Tablets. Int. J. Pharm. Sci. Nanotech. 2014, 7, 2671–2676.
   Google Scholar
• Pereira, C.; Barros, L.; Carvalho, A. M.; Ferreira, I. C. F. R. Use of UFLC-PDA for the Analysis of Organic Acids in Thirty-Five Species of Food and Medicinal Plants. Food Anal. Methods. 2013, 6, 1337–1344.
   Web of Science ®Google Scholar
• Zhang, Y.; Li, Q.; Lv, C.; Yin, Y.; Bi, K. A UFLC/MS/MS Method for Simultaneous Quantitation of Alisol A and Alisol B 23-Acetate from Alisma Orientale (Sam.) Juz. in Rat Plasma. Asian J. Pharm. Sci. 2014, 9, 279–285.
   Google Scholar
• Liu, Y.; Ma, H.; Seeram, N. P. Development and UFLC-MS/MS Characterization of a Product-Specific Standard for Phenolic Quantification of Maple Derived Foods. J. Agric. Food Chem. 2016, 64, 3311–3317.
   PubMed Web of Science ®Google Scholar
• Ali, I.; Dutta, K. K.; Jain, A. K.; Alothman, Z. A.; Alwarthan, A. Synchronized Fast SPE and UFLC Methods for the Analyses of Eight Antidiabetic Drugs in Human Plasma. Comb. Chem. High Throughput Screen. 2017, 20, 208–214.
   PubMed Web of Science ®Google Scholar
• O’Neil, M. J. Antispasmodic. In The Merck Index, 14th ed.; Merck Research Laboratories, Merck & Co., Inc.: Whitehouse Station, NJ, 2006; p. 996.
   Google Scholar
• Annahazi, A.; Roka, R.; Rosztoczy, A.; Wittmann, T. Role of Antispasmodics in the Treatment of Irritable Bowel Syndrome. World J. Gastroenterol. 2014, 20, 6031–6043.
   PubMed Web of Science ®Google Scholar
• Arayne, M. S.; Sultana, N.; Siddiqui, F. A. A New RP-HPLC Method for Analysis of Mebeverine Hydrochloride in Raw Materials and Tablets. Pak. J. Pharm. Sci. 2005, 18, 11–14.
   PubMedGoogle Scholar
• Radwan, M. A.; Abdine, H. H.; Hassan, Y. A.-E. A Validated Chiral HPLC Method for the Determination of Mebeverine HCl Enantiomers in Pharmaceutical Dosage Forms and Spiked Rat Plasma. Biomed. Chromatogr. 2006, 20, 211–216. DOI:10.1002/bmc.556.
   PubMed Web of Science ®Google Scholar
• Naguib, I. A.; Abdelkawy, M. Development and Validation of Stability Indicating HPLC and HPTLC Methods for Determination of Sulpiride and Mebeverine Hydrochloride in Combination. European J.Med. Chem. 2010, 45, 3719–3725. DOI:10.1016/j.ejmech.2010.05.021.
   PubMed Web of Science ®Google Scholar
• Srinivasan, V.; Sivaramakrishnan, H.; Karthikeyan, B.; Balaji, T. S.; Vijayabaskar, S. Stress Degradation Studies on Mebeverine Hydrochloride and Development of a Validated Stability Indicating UPLC Method. J. Liq. Chromatogr. Relat. Technol. 2011, 34, 1631–1644. DOI: 10.1080/10826076.2011.576297.
   Web of Science ®Google Scholar
• Souri, E.; Negahban Aghdami, A.; Adib, N. A Stability Indicating HPLC Method for Determination of Mebeverine in the Presence of Its Degradation Products and Kinetic Study of Its Degradation in Oxidative Condition. Res. Pharm. Sci. 2014, 9, 199–206.
   PubMedGoogle Scholar
• Reddy, P. R. K.; Reddy, V. K.; Goud, E. S.; Reddy, Y. R. Development and Validation of a Ultra Performance Liquid Chromatographic Method for Assay of Mebeverine Hydrochloride. Pharm. Anal. Acta. 2015, 6, 442–445.
   Google Scholar
• Senthil Kumar, K. R.; Meyanathan, S. N.; Gowramma, B. A New Validated Chiral RP-HPLC Method for the Determination of Stability of Mebeverine Hydrochloride in the Presence of Its Degradation Products. Int. J. Pharm. Pharma. Sci. 2015, 7, 112–116.
   Google Scholar
• Ramadevi; Srikanth, S.; Kumar, A. A. RP-HPLC Method Development and Validation for Simultaneous Quantitative Estimation of Mebeverine Hydrochloride and Chlordiazepoxide in Capsules. Int. J. Pharm. Pharm. Sci. 2015, 7, 314–318.
   Google Scholar
• Moskaleva, N. E.; Baranov, P. A.; Mesonzhnik, N. V.; Appolonova, S. A. HPLC-MS/MS Method for the Simultaneous Quantification of Desmethylmebeverine Acid, Mebeverine Acid and Mebeverine Alcohol in Human Plasma along with Its Application to a Pharmacokinetics Study. J. Pharm. Biomed. Anal. 2017, 138, 118–215. DOI: 10.1016/j.jpba.2017.02.006.
   PubMed Web of Science ®Google Scholar
• Kraemer, T.; Wennig, R.; Maurer, H. H. The Antispasmodic Drug Mebeverine Leads to Positive Amphetamine Results by Fluorescence Polarization Immunoassay (FPIA)-Studies on the Toxicological Analysis of Urine by FPIA and GC-MS. J. Anal. Toxicol. 2001, 25, 333–338.
   PubMed Web of Science ®Google Scholar
• ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology, Q2 (R1). Current Step 4 Version, Parent Guidelines of Methodology, 2005. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf (accessed Feb 11, 2018)
   Google Scholar