NEW STABILITY-INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ROSUVASTATIN (CALCIUM) IN PHARMACEUTICAL DOSAGE FORMS
Abstract
A stability indicating, accurate, specific, linear and sensitive reverse phase-HPLC method was developed and validated for the determination of Rosuvastatin calcium (ROS) in pharmaceutical dosage form. The chromatographic separation was performed using Eclipse XDB plus C18 Column (4.6 × 150 mm, 5μm particle size). Mobile phase was made by using Acetonitrile: Water (60:40 v/v) at a flow rate of 1.0 ml/min with the detection wavelength at 242 nm. The retention time of ROS was found to be about 1.787 min. The linearity was obtained in the concentration range of 10-50 μg/ml with a correlation coefficient of 0.999. The percentage purity of ROS was found to be 100.06 %. The percentage recovery was determined for ROS and found to be 100.53 %. The developed analytical method was validated for linearity, precision, accuracy, ruggedness, robustness, specificity and system suitability which were within the acceptance limit according to ICH guidelines. All the degradation products obtained by stress conditions were found to be well separated from the principal peak, which means that the ROS peaks were highly pure in all chromatograms obtained. The developed method was found to be applicable for routine quality control and stability analysis of ROS in pharmaceutical dosage forms.
Keywords:
Rosuvastatin Calcium, Stability-Indicating, RP-HPLC, ValidationDOI
https://doi.org/10.25004/IJPSDR.2014.060405References
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2. Sumalatha M, Haritha Pavani K. Analytical method development and validation for the simultaneous estimation of Rosuvastatin and Fenofibrate in tablet dosage form by reverse phase high performance liquid chromatography. Indian Journal of Research in Pharmacy and Biotechnology 2013; 1: 850-856.
3. Thriveni J, Rambabu R, Venkateswara Rao J, Vidyadhara S. Development and validation of RP-HPLC method for simultaneous estimation of Rosuvastatin calcium and Fenofibrate in bulk and pharmaceutical dosage forms. International Journal of Research in Pharmacy and Chemistry 2013; 3: 208-212.
4. Devika GS, Sudhakar M, Venkateshwara Rao J. A new improved RP-HPLC method for simultaneous estimation of Rosuvastatin calcium and Fenofibrate in tablets. International Journal of Pharmacy and Pharmaceutical Sciences 2011; 3: 311-315.
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6. Hasumati Raj A, Sadhana Rajput J, Jayant Dave B, Chaggan Patel N. Development and validation of two chromatographic stability-indicating methods for determination of Rosuvastatin In pure form and pharmaceutical preparation. International Journal of ChemTech Research 2009; 1: 677-89.
7. Varma PSRChNPD, Lakshmana Rao A, Dinda SC. Development and validation of stability indicating RP-HPLC method for simultaneous estimation of Rosuvastatin and Ezetimibe in combined tablet dosage form. Rasayan J Chem. 2012; 5: 269-79.
8. Turabi ZM, Atef Khatatbeh O. Stability-indicating RP-HPLC method development and validation for the determination of Rosuvastatin (calcium) in pharmaceutical dosage form. International Journal of Pharmaceutical Sciences and Drug Research 2014; 6: 154-159.
9. Reddy GVR, Reddy BV, Haque SW, Gautam HD, Kumar P. Development and validation of a stability-indicating UPLC method for Rosuvastatin and its related impurities in pharmaceutical dosage forms 2011; 34: 250-255.
10. Sahu S, Narayan UL, Garnaik B, Patro SK. Stability Indicating RP-HPLC method for determination of Ezetimibe in pure and pharmaceutical formulation. International Journal of Research in Pharmaceutical and Biomedical Sciences 2013; 4: 1249-1255.
11. Divya A, Raveendra Reddy J, Ramalingam P. Simultaneous estimation of Aspirin and Rosuvastatin calcium in dosage forms by RP-HPLC and its application to Forced Degradation Studies. Journal of Pharmacy Research 2012; 5: 5081-5083.
12. Mehta TN, Patel AK, Kulkarni GM, Suubbaiah G. Determination of Rosuvastatin in the presence of its degradation products by a Stability-Indicating LC method. Journal of AOAC International 2005; 88: 1142-1147.
13. Kumar P, Ahmad Y, Ghosh A. A stability indicating RP-HPLC method development for determination of Ezetimibe in tablet dosage form. Der Pharma Chemica. 2012; 4: 1296-1304.
14. Park JW, Byun SY, Park YH, Lim KS. Stability studies of Rosuvastatin calcium and Aspirin in combined capsule dosage form. Int J Pharm Biomed Sci. 2014; 5: 09-16.
15. Trivedi HK, Mukesh Patel C. Development and validation of a Stability-indicating RP-UPLC method for determination of Rosuvastatin and related Substances in pharmaceutical dosage form. Sci Pharm. 2012; 80: 393–406.
16. Vyas S, Raval K, Antala H. Development and validation of derivative spectroscopic method for the simultaneous estimation of Rosuvastatin calcium and Fenofibrate in combined dosage form. International Journal of Research in Pharmaceutical and Nano Sciences 2013; 2: 158-168.
17. Patel B, Jadav A, Solanki H, Parmar S, Parmar V, Captain A. Development and validation of derivative spectroscopic method for the simultaneous estimation of Rosuvastatin calcium and Fenofibrate in tablet. International Journal of Pharma Research & Review 2013; 2: 1-6.
18. Parmar VK, Solanki H, Prajapati L. Derivative spectrophotometric determination of Rosuvastatin calcium and Fenofibrate in tablet dosage form. Inventi Rapid: Pharm Analysis & Quality Assurance 2013; 2: 1-5.
19. Prashant MS, Pratik PR, Agarwal KM, Surana SJ. Q-Absorbance and multicomponent UV - Spectrophotometric methods for simultaneous estimation of Rosuvastatin calcium and Fenofibrate in pharmaceutical formulation. Scholars Research Library Der Pharmacia Lettre. 2012; 4: 1054-1059.
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21. Code Q2B - Analytical validation & Methodology, 1996, ICH Harmonized Tripartite Guideline.
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2. Sumalatha M, Haritha Pavani K. Analytical method development and validation for the simultaneous estimation of Rosuvastatin and Fenofibrate in tablet dosage form by reverse phase high performance liquid chromatography. Indian Journal of Research in Pharmacy and Biotechnology 2013; 1: 850-856.
3. Thriveni J, Rambabu R, Venkateswara Rao J, Vidyadhara S. Development and validation of RP-HPLC method for simultaneous estimation of Rosuvastatin calcium and Fenofibrate in bulk and pharmaceutical dosage forms. International Journal of Research in Pharmacy and Chemistry 2013; 3: 208-212.
4. Devika GS, Sudhakar M, Venkateshwara Rao J. A new improved RP-HPLC method for simultaneous estimation of Rosuvastatin calcium and Fenofibrate in tablets. International Journal of Pharmacy and Pharmaceutical Sciences 2011; 3: 311-315.
5. Karunakaran A, Vetsa S, Chinthala R, Muthuvijayan J. Simultaneous estimation of Rosuvastatin calcium and Fenofibrate in bulk and in tablet dosage form by UV-Spectrophotometry and RP-HPLC. Stamford Journal of Pharmaceutical Sciences 2011; 4: 58-63.
6. Hasumati Raj A, Sadhana Rajput J, Jayant Dave B, Chaggan Patel N. Development and validation of two chromatographic stability-indicating methods for determination of Rosuvastatin In pure form and pharmaceutical preparation. International Journal of ChemTech Research 2009; 1: 677-89.
7. Varma PSRChNPD, Lakshmana Rao A, Dinda SC. Development and validation of stability indicating RP-HPLC method for simultaneous estimation of Rosuvastatin and Ezetimibe in combined tablet dosage form. Rasayan J Chem. 2012; 5: 269-79.
8. Turabi ZM, Atef Khatatbeh O. Stability-indicating RP-HPLC method development and validation for the determination of Rosuvastatin (calcium) in pharmaceutical dosage form. International Journal of Pharmaceutical Sciences and Drug Research 2014; 6: 154-159.
9. Reddy GVR, Reddy BV, Haque SW, Gautam HD, Kumar P. Development and validation of a stability-indicating UPLC method for Rosuvastatin and its related impurities in pharmaceutical dosage forms 2011; 34: 250-255.
10. Sahu S, Narayan UL, Garnaik B, Patro SK. Stability Indicating RP-HPLC method for determination of Ezetimibe in pure and pharmaceutical formulation. International Journal of Research in Pharmaceutical and Biomedical Sciences 2013; 4: 1249-1255.
11. Divya A, Raveendra Reddy J, Ramalingam P. Simultaneous estimation of Aspirin and Rosuvastatin calcium in dosage forms by RP-HPLC and its application to Forced Degradation Studies. Journal of Pharmacy Research 2012; 5: 5081-5083.
12. Mehta TN, Patel AK, Kulkarni GM, Suubbaiah G. Determination of Rosuvastatin in the presence of its degradation products by a Stability-Indicating LC method. Journal of AOAC International 2005; 88: 1142-1147.
13. Kumar P, Ahmad Y, Ghosh A. A stability indicating RP-HPLC method development for determination of Ezetimibe in tablet dosage form. Der Pharma Chemica. 2012; 4: 1296-1304.
14. Park JW, Byun SY, Park YH, Lim KS. Stability studies of Rosuvastatin calcium and Aspirin in combined capsule dosage form. Int J Pharm Biomed Sci. 2014; 5: 09-16.
15. Trivedi HK, Mukesh Patel C. Development and validation of a Stability-indicating RP-UPLC method for determination of Rosuvastatin and related Substances in pharmaceutical dosage form. Sci Pharm. 2012; 80: 393–406.
16. Vyas S, Raval K, Antala H. Development and validation of derivative spectroscopic method for the simultaneous estimation of Rosuvastatin calcium and Fenofibrate in combined dosage form. International Journal of Research in Pharmaceutical and Nano Sciences 2013; 2: 158-168.
17. Patel B, Jadav A, Solanki H, Parmar S, Parmar V, Captain A. Development and validation of derivative spectroscopic method for the simultaneous estimation of Rosuvastatin calcium and Fenofibrate in tablet. International Journal of Pharma Research & Review 2013; 2: 1-6.
18. Parmar VK, Solanki H, Prajapati L. Derivative spectrophotometric determination of Rosuvastatin calcium and Fenofibrate in tablet dosage form. Inventi Rapid: Pharm Analysis & Quality Assurance 2013; 2: 1-5.
19. Prashant MS, Pratik PR, Agarwal KM, Surana SJ. Q-Absorbance and multicomponent UV - Spectrophotometric methods for simultaneous estimation of Rosuvastatin calcium and Fenofibrate in pharmaceutical formulation. Scholars Research Library Der Pharmacia Lettre. 2012; 4: 1054-1059.
20. Code Q2A - Text on validation of analytical procedure, 1994, ICH Harmonized Tripartite Guideline.
21. Code Q2B - Analytical validation & Methodology, 1996, ICH Harmonized Tripartite Guideline.
22. Code Q2R1 - Validation of analytical procedures text and methodology, 2005, ICH Harmonized Tripartite Guideline.
Published
01-10-2014
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“NEW STABILITY-INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ROSUVASTATIN (CALCIUM) IN PHARMACEUTICAL DOSAGE FORMS”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 6, no. 4, Oct. 2014, pp. 283-90, https://doi.org/10.25004/IJPSDR.2014.060405.
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How to Cite
“NEW STABILITY-INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ROSUVASTATIN (CALCIUM) IN PHARMACEUTICAL DOSAGE FORMS”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 6, no. 4, Oct. 2014, pp. 283-90, https://doi.org/10.25004/IJPSDR.2014.060405.
