Method Development and Validation for Simultaneous Estimation of Benidipine Hydrochloride and Metoprolol Succinate in Tablet
Present work focusing in developing and validating a new high performance liquid chromatography method for estimation of Metoprolol Succinate and Benidipine Hydrochloride in their combine tablet dosage form. The method was performed on Shimadzu LC-20AT instrument using C18 (250 mm x 4.6 mm, 5 µm) Hypersil BDS Column and Potassium Dihydrogen Phosphate Buffer (pH 4.0): Methanol (65: 35% v/v) as mobile phase at ambient temperature. Detection was carried out at 269 nm. Concentration range 4-12 µg/ml for Benidipine Hydrochloride and 25-75 µg/ml for Metoprolol Succinate . The Percentage recovery of Benidipine Hydrochloride and Metoprrolol succinate was found to be 99.59% and 99.39 respectively. Correlation coefficient for Metoprolol succinate and Benidipine Hydrochloride was found 0.9995 and 0.9997 respectively. The Rt values for Metoprolol succinate and Benidipine Hydrochloride were found to be 3.4 and 5.9 min respectively. The method was validated according to the guidelines of International Conference on Harmonisation (ICH) and was successfully employed in the estimation of commercial formulations.
Keywords: Metoprolol Succinate, Benidipine Hydrochoride, HPLC, Mobile Phase,
2) United States Pharmacopeia and National Formulary (USP 30-NF 25). Vol 30 (3). Rockville, MD: United States Pharmacopeial Convention; Asian Edition, 2007 : 2647-2649.
3) Gold T, Shterman N. Metoprolol succinate extended release tablets and methods for their preparation . European Patents EP20060252598, 2007.
4) Qinghua Z, Bo C, Guangyu X, Huafeng D. Preparation method of benidipine hydrochloride. China’s Patent CN 201310611167, 2015
5) Aqil M, Ali A, Ahad A, Sultana Y, Najmi AK, Saha N. A Validated HPLC Method For Estimation of Metoprolol in Human Plasma. Acta Chrom 2007; 19: 130-140
6) Phale MD, Hamrapurkar PD. .A Validated and Simplified RP-HPLC of Metoprolol Succinate from Bulk Drugs. Asian Journal of Research in Chemistry 2009 ;2(2): 119-122
7) Chandana M, Rao MP, Ramya B, Sagar DV, Marsis DT, Gnana R, Anilkumar K, Haritha K .Quantification of Metoprolol Succinate in bulk and tablet formulation by HPLC: Method development and validation. European Journal Of Pharmacy and Reaserch 2016; 11(4): 31-40
8) Kalisetty S, Reddy TS, Reddy AM, Palnati JB, Rao DV, Manikandan R. Stability Indicating Reverse phase Liquid chromatographic Method for the Determination of Metoprolol succinate in Pharmaceutical dosage forms” Journal of chemistry and pharmaceutical Reasech., 2012; 4(9): 4420-4425
9) Kumar CH, Munnari S, Kuchana V, Kannappan N, Development and validation of a stability indicating RP-HPLC method for determination of Metoprolol Succinate in pharmaceutical dosage forms. Der Pharm. Sinica, 2014 ;5(6): 69-78
10) Shitole SV, Gurjar M, Shah M, Bal G, Pimple S, Patel R,. Stability Indicating RP-HPLC Method for Quantitative Estimation of S (-) Metoprolol Succinate in tablet dosage form. Americal Jornal of Pharmtech Research 2014; 4(5) : 712-721.
11) Saravanan G, Pamarthi NP, Jeneyellu IS, Visagaperumal D., Development And Validation of Stability Indicating RP-HPLC method for the simultaneous estimation of Metoprolol Succinate and Cilnidipine in bulk and pharmaceutical dosage form. International Journal of pharmaceutical sciences. 2014 ; 7(1): 150-154.
12) Madhukar A, Kannapan N,. RP-HPLC Method for the Simultaneous Estimation of Cilnidipine and Metoprolol Succinate in Bulk and tablet dosage form in Biorelevant Media (FaSSIF). International journal of pharmaceutical technology and reaserch. 2014-2015, 7(1), 172-184.
13) Kumar TH, Sankar DG, Stability Indicating RP-HPLC Method Development And Validation For Simultaneous estimation of Metoprolol Succinate and Cilnidipine in bulk and pharmaceutical formulation. Indo americal journal of pharmaceutical sciences., 2016 ; 6(4) : 5338-5350.
14) Godse VP, Bhosale AV, Bafana YS, Borkar DD, Stability-Indicating HPLC method for simultaneous determination of Metoprolol Succinate and Hydrochlorothiazide in combination drug products . International Journal of chemistry and sciences.2009; 7(3): 1733-1745.
15) Chitlange SS, Bhusal RD, Nikumbh MB, Bhole RP,. Development and validation of spectrophotometric and stability indicating RP-HPLC method for the simultaneous estimation of Metoprolol Succinate and Hydrochlorothiazide in tablet dosage form. International Journal of Pharmacy., 2012; 2(3): 591-597.
16) Chitlange SS, Imran M, Sakarkar DM, RP-HPLC method for simultaneous estimation of amlodipine and metoprolol in tablet formulation. Asian journal of Pharmacy , 2008;1 : 232-234
17) Varma D, Rao AL, Dinda SC, Validated Stability Indicating HPLC method for simultaneous determination of Amlodipine and Metoprolol in bulk drug and pharmaceutical formulations. International journal of pharmacy and chemistry. 2012; 2(3) :876-884.
18) Shitole S, Gurjar M, Shah M, Pimple S, Bal G, Patel R. Development and validation of stability indicating RP-UPLC method for simultaneous determination of related substances of S (-) Amlodipine and S (-) Metoprolol succinate in fixed dose combination tablet dosage form. International Journal of pharmacy., 2009; 2(3):146-152.
19) Chandrabatala V, Ramkrishna K,.Gradient RP-HPLC Method for simultaneous estimation of Metoprolol, Ramipril and Atorvastatin in tablet dosage form. Rasayan Journal of Chemistry., 2015; 8(4): 404-410.
20) Shaikh KA, Patil AT, Stress degradation studies of Telmisartan and Metoprolol extended release tablets by a validated stability indicating reverse phase-high performance liquid chromatography method.Drug development and thearapeutics., 2014; 5(2): 158-163.
21) Yunooos M, Sankar DG, .Stability indicating reverse phase LC method development and validation for simultaneous estimation of metoprolol succinate and chlorthalidone in combined tablet dosage form. Der pharmaceutica 2015; 7(4): 162-172.
22) Bari SB, Patil MS, Validated and Stability indicating of RP-HPLC method for simultaneous estimation of S(-)Metoprolol Succinate & Clopidogrel Bisulfate in bulk and tablet dosage form. International Journal of innovative research and development. 2013; 2(7): 484-489.
23) Thakker NM, Panchal HB, Rakholiya DR, Murugan R, Choudhry VP, Kuchekar BS, Development and validation of a stability indicating RP-HPLC method for simultaneous estimation of Olmesartan Medoxomil and Metoprolol Succinate in pharmaceutical dosage form. Pharmaceutical. Methods, 2012; 3(2) :84-89.
24) Hinge MA, Mahida RJ, Sojitra PS, Development and Validation of an RP-HPLC Method for Simultaneous determination of Trimetazidine Hydrochloride and Metoprolol Succinate. Internatioanl Journla of Chemistry and pharmaceutical analysis., 2015; 2(2): 77-83.
25) Singhvi I, Chaturvedi SC, Spectrophotometric method for estimation of Amlodipine Besylate and Benidipine Hydrochloride from Tablet, Indian journal of pharmaceutical sciences, 1999:190-191
26) Magara H, Kobayashi H, Kobayashi S. Determination of benidipine hydrochloride in human plasma by capillary column gas chromatography—negative ion chemical ionization mass spectrometry. Journal of Chromatography. B, 1993 ; 617(1): 59-63
27) Atici EB, Karliga B,. Identification, synthesis and characterization of process related impurities of benidipine hydrochloride, stress-testing/stability studies and HPLC/UPLC method validations Journal Of Pharmaceutical Analysis, 2015; 5:265-268
28) Willard HH, Merritt LL, Dean JA, Settle FA, Instrumental Methods of Analysis , 7th Edition CBS Publishers & Distributors, New Delhi – 110002, India , 1988 ; 160 -178 .
29) Proceedings of the International Conference on Harmonization (ICH), Q2B: Text on Validation of Analytical Procedures: Definitions and Terminology, USFDA Federal Register; 1995.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).