Development and Validation of Rp-HPLC Method for Analysis of Raloxifene in Pharmaceutical Dosage Forms

Development and Validation of Rp-HPLC Method for Analysis of Raloxifene in Pharmaceutical Dosage Forms

Venu Manukonda1, Shaheen Sultana2*, Amit Singh3, Maria Khan2, Mohammad Yusuf2, Ibrahim Abdullah Maghrabi2

1RV Northland Institute;2Taif University, Saudi Arabia;3RV Northland Institute

Journal of Pharmaceutical Research and Reviews

The aim of present work was to develop and validate a simple, fast and reliable isocratic HPLC method for determination of raloxifene hydrochloride in pharmaceutical dosage form. Chromatographic Separation was achieved by using Agilent technologies model G4288A. Gradient HPLC-1120 , Compact low pressure binary Gradient Pump Consisting Of vacuum in built degasser unit non-PDA UV-vis detector equipped with a manual injection system with 50 uL loop and the eluted analytes for drug was traced by UV detection at 287nm. The method was found to be linear over a wide concentration range (0.1-20 µg/mL) with a correlation coefficient (r) of 0.9995. The LOD and LOQ were 21 and 63 ng/mL for RLX. These results indicate that method is sensitive enough for therapeutic assay. The % RSD values for three selected concentrations were found to be 0.14, 0.51 and 0.75% revealed the high system accuracy. The relative standard deviations (RSD) obtained at three concentrations (n = 6) in the range of 8-10 µg/mL was 0.016-0.018 % for the intraday assay and 0.016-0.024% for interday assay revealed good precision. The specificity was demonstrated that drugs were free of interference from potential impurities. % RSD, theoretical plates and Rmin were not significantly affected when the experimental parameters (such as flow rate, gradient program) were altered and thus concluded that the method was robust.

Keywords: Raloxifene; HPLC, linearity, robustness

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How to cite this article:
Venu Manukonda, Shaheen Sultana, Amit Singh, Maria Khan, Mohammad Yusuf, Ibrahim Abdullah Maghrabi. Development and Validation of Rp-hplc Method for Analysis of Raloxifene in Pharmaceutical Dosage Forms. Journal of Pharmaceutical Research and Reviews, 2018; 2:7.


1. Pavan kumar Bathini, Venkata Ramana Kandula, Prashanth Reddy Gaddameedhi (2009). An improved synthesis of raloxifene hydrochoride: a selective estrogen receptor modulator. Coden HLEEAI, 2014; 4(4): 515-518.
2. Enrico M Messalli, Cono Scaffa. Long-term safety and efficacy of raloxifene in the prevention and treatment of postmenopausal osteoporosis: an update. International Journal of Womens Health, 2009; 1: 11–20.
3. Buridi Kalyanaramu, K. Raghubabu. Determination of Raloxifene Hydrochloride By Oxidative Coupling Reaction In Pharmaceutical Formulations. International Journal of Applied Pharmaceutics, 2011; 3(2): 6¬9.
4. Nagaraju PT, K Venu Gopal, Murali Krishna NV, Bhargavi V, Srinivasulu N. UV – Spectrophotometric Method Development and Validation for Determination of Raloxifene in Pharmaceutical Dosage Form. Research & Reviews: Journal of Pharmaceutical Analysis, 2014; 3(4): 27-31.
5. Jurji Trontelj, Marija Bogataj, Janja Marc, Ales Mrhr. Development and validation of a LC‐MS‐MS assay for determination of raloxifene and its metabolites in human plasma. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 2007; 855(2): 220‐227.
6. Basavaiah Kanakapura, Anil Kumar UR, Tharpa K, Vinay KB. Determination of raloxifene in human urine by LC‐MS‐MS. Chemical Industry & Chemical Engineering Quarterly, 2009; 15(3): 119‐123.
7. Pérez-Ruiz T, Martínez-Lozano C, Sanz A, Bravo E. Development and validation of a quantitative assay for raloxifene by capillary electrophoresis. J Pharm Biomed Anal. 2004 Mar 10;34(5):891-7.
7. D Suneetha, A. Lakshmana Rao. A New Validated Rp-Hplc Method For The Estimation Of Raloxifene In Pure And Tablet Dosage Form. Rasayan Journal of chemistry, 2010; 3(1): 117-121.
8. Mohammad Nasir Uddin, Suman Das, Shakhawat Hasan Khan, Swapon Kumar Shill, Habibur Rahman Bhuiyan, Rezaul Karim. Simultaneous determination of amoxicillin and chloramphenicol and their drug interaction study by the validated UPLC method. Journal Taibah University of Science, 2016; 10: 755–765.
9. ICH Harmonized Tripartite, Validation of Analytical Procedures: Text and Methodology Q2 (R1), Current Step 4 Version, Parent Guidelines on Methodology Dated November 6, 1996, Incorporated in November 2005, in: International Conference on Harmonisation, Geneva, Switzerland, 1996.