DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF METOPROLOL SUCCINATE AND CILNIDIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM
Keywords:
Metoprolol succinate, Cilnidipine, RP-HPLC, Acetonitrile, Sodium dihydrogen ortho phosphate, Orthophosphoric acid, MethanolAbstract
Objective: Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of Metoprolol succinate and Cilnidipine in bulk and pharmaceutical dosage form.
Methods: The separation was carried out on STD Kromasil 150 C18 (4.6 mm X 150 mm, 5 µ) column using acetonitrile: sodium dihydrogen ortho phosphate buffer (adjusted to pH 5 with 10 % OPA) in the ratio of 65: 35 % v/v as eluent. The flow rate was 0.8 ml/min and effluent was detected at 230 nm.
Results: The retention time of Metoprolol succinate and Cilnidipine were found to be 2.27 and 3.26 min, respectively. The linear dynamic range was 62.5-375 μg/ml for Metorolol succinate and 12.5-75 μg/ml for Cilnidipine, respectively. Percentage recoveries for Metoprolol succinate and Cilnidipine were 99.73 – 99.93 % and 99.92 – 99.96 %, respectively. All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method.
Conclusion: A simple, efficient and reproducible stability indicating RP-HPLC method for the simultaneous determination of Metoprolol Succinate and Cilnidipine in pharmaceutical dosage form has been developed and validated. The developed method was also found to be precise and robust for the simultaneous determination of Metoprolol succinate and Cilnidipine in tablet dosage forms.
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Bakshi M, Singh S. Development of validated stability indicating assay methods-Critical review. J Pharm Biomed Anal 2002;28(6):1011-40.
ICH harmonised tripartite guideline. Stability testing of new drug substances and products. ICH, Geneva; 2003. p. 1-18.
Pankaj P Chaudhari, Bhalerao AV. Method validation for spectrophotometric estimation of Cilnidipine. Int J Pharm Pharm Sci 2012;Suppl 5:96-8.
Jadhav AS, Tarkase KN, Deshpande AP. Quantitative determination of Metoprolol succinate in bulk and tablet dosage form through comparative study of UV and derivative spectroscopy. Scholars Res Lib Der Pharm Lett 2012;4(3):763-7.
Moreshwar N Kulkarni, Rajeshwar V Kshirsagar, Dinesh M Sakarkar. Development and validation of spectrophotometric method for determination of Metoprolol succinate. Int J Chem Tech Res 2009;1(4):1273-7.
Soni M Vaghela, Pinak Patel, Jagadish L Kak adiya, Nehal J Shah. Development and validation of RP-HPLC method for simultaneous estimation of Cilnidipine and Metoprolol succinate in their combined pharmaceutical dosage form. Inventi Rapid: Pharm Analysis Quality Assurance 2014.
Prajakta Pawar, Santosh V Gandhi, Padmanabh B Deshpande, Suvarna Vanjari, Swapnil U Shelar. Simultaneous RP-HPLC estimation of Cilnidipine and Telmisartan in combined tablet dosage form. Pelagia Res Lib Der Chem Sin 2013;4(2):6-10.
Sidhdhapara Mital J, Biraju Patel, Ashok Paramar. Development and validation of RP-HPLC method for simultaneous estimation of Cilnidipine and Olmesartan medoxomil in their combined tablet dosage form. Int J Pharm Bio Sci 2014;4(1):157-60.
Mitesh D Phale, Purnima D Hamrapurkar. A validated and simplified RP-HPLC of Metoprolol succinate from bulk drugs. Asian J Res Chem 2009;2(2):119-22.
Jadhav AS, Tarkase KN, Deshpande AP. Quantitative determination of Metoprolol succinate in bulk and tablet dosage form through comparative study of UV and derivative spectroscopy. Scholars Res Lib Der Pharm Lett 2012;4(3):763-7.
Hesham Salem, Ola M Abdallah. Determination of Metoprolol and Felodipine in binary mixture using chemometric-assisted spectrophotometric and high-performance liquid chromatographic-UV methods. Ame J App Sci 2007;4(9):709-17.
Vaghela Soni, Jagdish Kakadiya, Pinak Patel, Nehal Shah. Development and validation of high performance thin layer chromatographic method for Cilnidipine and Metoprolol succinate in their combined pharmaceutical dosage form. Int J Res Pharm Nano Sci 2014;3(1):61-72.
Kyeong-Ryoon Lee, Yoon-Jee Chae, Jong-Hwa Lee, Dae-DukKim, Saeho Chong, Chang-Koo Shim, et al. Quantification of Cilnidipine in human plasma by liquid chromatography-mass spectrometry. J Liq Chrom Rel Tech 2012;35(2):308-20.
Lee HW, Seo JH, Lee HS, Jeong SY, Cho YW, Lee KT. Development of a liquid chromatography/negative-ion electrospray tandem mass spectrometry assay for the determination of Cilnidipine in human plasma and its application to a bioequivalence study. J Chromatogr B: Anal Tech Biomed Life Sci 2012;862(1-2):246-51.
Raja Reddy Kallem, Mullangi Ramesh, Seshagirirao JVLN. Validated LC-ESI-MS/MS method for simultaneous quantitation of Felodipine and Metoprolol succinate in rat plasma: application to a pharmacokinetic study in rats. Biomed Chrom 2013;27(6):784-91.
US Food and drug administration. Guidance for industry: Q2B validation of analytical procedures: methodology, Rockville; 1996.
US FDA. Guideline for industry: text on validation of analytical procedures: ICH Q2A. Rockville, MD: 1995.
International conference on harmonization (ICH), ICH quality guidelines: Good manufacturing practice guidance for active pharmaceutical ingredients Q7A (ICH, Geneva, Switzerland; 2001.
US Food and drug administration, Guidance document for industry, Analytical procedures and methods validation,†FDA, Rockville, MD; 2000.
ICH, ICH Quality guidelines validation on analytical procedures: Methodology Q2B (ICH, Geneva, Switzerland; 1996.