VALIDATED RP-HPLC METHOD AND UNIQUE MOBILE PHASE FOR THE SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND VALSARTAN FROM SOLID DOSAGE FORM AND ROSUVASTATIN AND VALSARTAN FROM BULK
DOI:
https://doi.org/10.22159/ajpcr.2019.v12i4.31878Keywords:
Amlodipine besylate, Valsartan, Rosuvstatin, RP-HPLC, ChromatographAbstract
Objective: A reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of amlodipine besylate (AD) and valsartan (VAL) in pharmaceutical dosage form, and rosuvastatin (RV) and VAL from the bulk mixture.
Method: Chromatographic separation was performed on RP-C18 column. The optimized unique mobile phase (acetonitrile:water and pH adjusted to 4.8 with acetic acid) was pumped at a flow rate of 0.8 ml/min in the ratio of 75:25% v/v, and the eluents were monitored at 245 nm.
Results: The assay was performed with tablet and percentage of assay was found to 101.39 for AD and 100.05 for VAL, respectively, and with bulk mixture, percentage of assay was found to 99.58 for RV and 100.32 for VAL, respectively. Linearity was obtained in the concentration range of 1–12 μg/ml for AD, 5–50 μg/mL for VAL, and 2–20 μg/ml for RV. The method was statistically validated and RSD was found to be <2%, indicating high degree of accuracy and precision of the proposed RP-HPLC method.
Conclusions: The method suggests usefulness of unique mobile phase during the estimation of two or more multicomponent dosage forms. Due to its simplicity, rapidness, high precision, and accuracy, the proposed RP-HPLC method can be applied for simultaneous determination of AD and VAL in pharmaceutical dosage form, and RV and VAL in bulk mixture.
Downloads
References
Beale JM Jr., Block JH. Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry. 12th ed. New Delhi: Wolters Kluwer (India) Pvt., Ltd.; 2011. p. 614-54.
Lemke TL, Williams DA, Roche VF, William Zito S. Foyes Principles of Medicinal Chemistry. 7th ed. New Delhi: Wolters Kluwer (India) Pvt., Ltd.; 2013. p. 762-826.
The Royal Society of Chemistry. The Merck Index, An Encyclopaedia of Chemicals, Drugs and Biological. 15th ed. Cambridge UK: The Royal Society of Chemistry; 2013. p. 87, 1840, 1540.
Allen LV Jr., editor. Remington, the Science and Practice of Pharmacy. 22nd ed., Vol. 1. London: Pharmaceutical Press; 2013. p. 1322.
Brayfield A. Martindale (The Complete Drug Reference). 38th ed. London: Pharmaceutical Press; 2014(A). p. 632.
Hemke A, Bhure M, Anjankar V, Gupta K. Validated RP-HPLC method for simultaneous determination of amlodipine, hydrochlorothiazide and valsartan in pharmaceutical formulation. Int J Pharm Technol 2013;5: 5383-92.
Kavathia A, Misra M. Development and validation of RPHPLC and UV spectrophotometric method for rapid simultaneous estimation of amlodipine and benzepril in pure and fixed dose combination. Arab J Chem 2017;10 Supp 2:3021-8.
Modi JG, Patel JK. Stability indicating RP HPLC method for the simultaneous determination of amlodipine besylate and azilsartan medoxomil in tablet dosage form. Indian Drugs 2016;53:51-61.
Chhalotiya VK, Sindhav JR, Shah DA, Mehta FA, Bhat KK. Simultaneous estimation of moxonidine and amlodipine besylate in their pharmaceutical dosage form by stability indicating LC method. Indian Drugs 2016;53:24-31.
Solanki TB, Shah PA, Patel KG. Central composite design for validation of HPLC method for simultaneous estimation of olmesartan, medoxomil, amlodipine besylate and hydrochlorothiazide in tablets. Indian J Pharm Sci 2014;76:179-87.
Wankhede SB, Raka KC, Wadkar SB, Chitlange SS. Spectrophotometric and HPLC methods for simultaneous estimation of amlodipine besilate, losartan potassium and hydrochlorothiazide in tablets. Indian J Pharm Sci 2010;72:136-40.
EI-Gizaway SM, Abdelmageed OH, Omar MA, Deryea SM, Abdel-Megied AM. Development and validation of HPLC method for simultaneous determination of amlodipine, valsartan, hydrochlorothiazide in dosage form and spiked human plasma. Am J Anal Chem 2012;3:422-30.
Talele GS, Porwal PK. Development of validated bioanalytical HPLC-UV method for simultaneous estimation of amlodipine and atorvastatin in rat plasma. Indian J Pharm Sci 2015;77:742-50.
Jain PS, Patel MK, Bari SB, Surana SJ. Development and validation of HPTLC method for simultaneous determination of amlodipine besylate and metoprolol succinate in bulk and tablets. Indian J Pharm Sci 2012;74:152-6.
Pandya J, Sanyal M, Pranav S. Simultaneous densitometric analysis of amlodipine, hydrochlorothiazide, lisinopril and valsartan by HPTLC in pharmaceutical formulations and human plasma. J Liq Chromatogr Related Technol 2017;40:467-78.
Vojta J, Jedli?ka A, Coufal P, Jane?ková L. A new, rapid, stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form. J Pharm Biomed Anal 2015;109:36-44.
Ghule AS, Thomas T, Joseph M, Navyasree KS, Bhat K. Simultaneous estimation of telmisartan, hydrochlorothiazide and amlodipine besylate in tablet preparation by chemo metric assisted spectrophotometric analysis. Indian Drugs 2018;55:59-66.
Usharani N, Divya K, Ashrtiha VV. Development and validation of UV derivative spectroscopic method for the determination of amlodipine besylate and valsartan in tablet dosage form and comparison of the developed methods by students’ test. Indian J Pharm Educ Res 2017;57: 776-82.
Saminathan J, Vetrichelvan T. UV spectrophotometric correction method for simultaneous estimation olmesartan, medoxomil, amlodipine besylate and hydrochlorothiazide in combined tablet dosage form. Indian Drugs 2017;54:33-8.
Patel MP, Patel MR, Hasumati R, Noolvi MN, Shah N. Simultaneous estimation amlodipine besylate and indapamide by dual wavelength spectrophotometric method for the combined pharmaceutical dosage form. Indian Drugs 2014;51:50-4.
Galande VR, Baheti KG, Indraksha S, Dehghan MH. Estimation of amlodipine besylate, valsartan and hydrochlorothiazide in bulk mixture and tablet by UV spectrophotometry. Indian J Pharm Sci 2012;74:18 23.
Al-Tamimi DJ, Maraie NK, Arafat T. Comparative bioavailability (bioequivalence) study for fixed dose combination tablet containing amlodipine, valsartan and hydrochlorothiazide using a newly developed HPLC-MS/MS method. Int J Pharm Pharm Sci 2016;8:296-305.
Sharma T, Si S. A validated gradient stability indicating LC method for the analysis of valsartan in pharmaceutical dosage form. Int J Pharm Pharm Sci 2016;8:128-33.
Kalyani R, Rao AL. Analytical method development and validation of alisikiren and valsartan in bulk and tablet dosage form by RP HPLC. Indian Drugs 2015;52:5-9.
Bianchini RM, Castellano PM, Kaufman TS. Characterization of two new potential impurities of valsartan obtained under photodegradation stress condition. J Pharm Biomed Anal 2011;56:16-22.
Virani P, Sojitra R, Raj H, Jain V. Chromatographic method for irbesartan and its combination with other drugs. J Crit Rev 2015;2:7-11.
Sreenivasa Reddy M, Kumar L, Attari Z, Verma R. Statistical optimization of extraction process for the quantification of valsartan in rabbit plasma by a HPLC method. Indian J Pharm Sci 2017;79:16-28.
del Rosario Brunetto M, Contreras Y, Clavijo S, Torres D, Delgado Y, Ovalles F, et al. Determination of losartan, telmisartan, and valsartan by direct injection of human urine into a column-switching liquid chromatographic system with fluorescence detection. J Pharm Biomed Anal 2009;50:194-9.
Krishnaiah Ch, Reddy AR, Kumar R, Mukkanti K. Stability-indicating UPLC method for determination of valsartan and their degradation products in active pharmaceutical ingredient and pharmaceutical dosage forms. J Pharm Biomed Anal 2010;53:483-9.
Ibrahim M. Investigation on thermal stability and purity determination of two antihypertensive drugs, valsartan and losartan potassium. Int J Curr Pharm Res 2015;7:64-9.
Kaila HO, Ambasana MA, Thakkar RS, Saravaia HT, Shah AK. A new improved RP HPLC method for assay of rosuvastatin calcium in tablet. Indian J Pharm Sci 2010;72:592-8.
Beludari MI, Prakash KV, Mohan GK. RPHPLC method for simultaneous estimation of rosuvastatin and ezetimibe from their combination dosage form. Int J Chem Anal Sci 2013;4:205-9.
Swathi Sri D, Hemant Kumar T, Vara Prasadarao K, Srinivasa Rao Y. Validated RP-HPLC method for simultaneous determination of rosuvastatin calcium and ezetimibe in pharmaceutical dosage form. Int J Pharm Pharm Sci 2015;7:209-13.
Shah A, Patel CN, Shah NJ. UV spectrophotometric method for simultaneous estimation of Rosuvastatin calcium and hydrochlorothiazide in their combined dosage forms. Indian Drugs 2018;55:63-6.
Singh R, Khan T. Analytical method development and validation studies for the estimation of aspirin, clopidogrel bisulphate and rosuvastatin calcium in fixed dose combination by UV spectroscopy. Indian Drugs 2017;54:43-7.
Kumar TR, Shitut NR, Kumar PK, Vinu MC, Kumar VV, Mullangi R, et al. Determination of rosuvastatin in rat plasma by HPLC: Validation and its application to pharmacokinetic studies. Biomed Chromatogr 2006;20:881-7.
Yulianita R, Sopyan I, Muchtaridi M. Forced degradation study of statins: A review. Int J Appl Pharm 2018;10:38-42.
British Pharmacopoeia. Medicines and Healthcare Products Regulatory Agency London: British Pharmacopoeia; 2015. p. I-153, II-1144.
Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare. The Indian Pharmacopoeia Commission. 7th ed., Vol. 2, 3. Ghaziabad: Indian Pharmacopoeia; 2014. p. 1045, 2684, 2951.
International Conference on Harmonization (ICH). Q2A: Text on Validation of Analytical Procedures: Definitions and Terminology. Vol. 60. US FDA Federal Register; 1995.
International Conference on Harmonization (ICH). Q2B: Validation of Analytical Procedures: Methodology. Vol. 62. US FDA Federal Register; 1997.
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.