CLEANING VALIDATION OF A SIMPLE AND RAPID REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF ASPIRIN AND ROSUVASTATIN
Objective: This study describes a new, simple, precise, accurate, and reproducible reversed-phase high-performance liquid chromatography (RP-HPLC) cleaning validation method for simultaneous estimation of rosuvastatin and aspirin.
Methods: The proposed RP-HPLC method was carried out on AGILENT-ZORBAX RP-Inertsil column (250 mm × 4.6 mm, 5 μm) in an isocratic mode utilizing potassium dihydrogen phosphate buffer (pH 2.5 with OPA):acetonitrile (50:50,v/v) as mobile phase, at a flow rate of 1.5 ml/min. Detection was carried out at 243 nm using UV detector.
Results: The method was found specific as there was no swab interference. The Beer–Lambert’s law was obeyed in the concentration range of 0.5–20 μg/ml for both rosuvastatin and aspirin. The mean percentage recoveries at 100% level were 89.4% for rosuvastatin and 82.1% for aspirin. The limit of detection and limit of quantification for rosuvastatin and aspirin were 0.03 μg/ml and 0.1 μg/ml, respectively. The method was found to be robust and precise with percentage RSD <2.0%.
Conclusion: A simple, novel, and economical RP-HPLC method for cleaning validation has been developed for the simultaneous estimation of rosuvastatin and aspirin. The method was validated as per ICH guidelines for specificity, linearity, accuracy, precision, and robustness. The developed method can be used as a sensitive analytical tool for ensuring the effectiveness of the cleaning procedure adopted.
2. Tripathi KD. Essentials of Medical Pharmacology. 7th ed. New Delhi: Jaypee Brothers Medical Publishers (P) Ltd.; 2013.
3. Yang P, Burson K, Feder D, MacDonald F. Method development of swab sampling for cleaning validation. J Pharm Technol 2005;29:84-94.
4. Ghosh A, Dey S. Overview of cleaning validation in pharmaceutical industry. Int J Pharm Qual Assur 2010;2:27-8.
5. Godavariya VD, Prajapati PB, Marolia B, Shah SA. Development and validation of RP-HPLC method for simultaneous estimation of rosuvastatin and aspirin in marketed formulation. Int Res J Pharm 2012;3:1735-45.
6. Solanki C, Patel N. Development and validation of RP-HPLC method for simultaneous estimation of rosuvastatin calcium and aspirin in capsule dosage form. Int J Pharm Biol Sci 2012;3:577-85.
7. Nazareth C, Shivakumar B, Reddy P. A novel RP HPLC method for the simultaneous estimation of cardiovascular drugs in a polycap formulation. World J Pharm Res 2018;7:677-87.
8. Nazareth C, Bodke A. Development and validation of a novel cleaning validation and assay method for simultaneous estimation of rosuvastatin and fenofibrate by RP HPLC. World J Pharm Res 2018;7:1454-65.
9. Nazareth C, Shivakumar B, Reddy P, Acharya S, Verekar S. A simple RP HPLC method for simultaneous estimation of six cardiovascular drugs in bulk and dosage form. IOSR J Pharm Biol Sci 2015;10:32-7.
10. Dumasiya M, Bhatt KK, Patel B, Joshi N. Development and validation of stability indicating RP-HPLC method for estimation of rosuvastatin calcium and aspirin in combined dosage form. Int J Pharm Sci 2012;3:2421-39.
11. Pandya CB, Channabasavaraj KP. Development and validation of RP-HPLC method for determination of rosuvastatin calcium in bulk and pharmaceutical dosage form. Int J Pharm Sci Rev Res 2010;5:82-6.
12. Turabi ZM, Khatatbeh OA. Stability-indicating RP-HPLC method development and validation for the determination of rosuvastatin (calcium) in pharmaceutical dosage form. Int J Pharm Sci Drug Res 2014;6:154-5.
13. Reddy GV, Reddy BV. Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms. Int Year Chem 2011;34:250-5.
14. Trivedi HK, Patel MC. 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.
15. Pisal P, Nigade G, Kale A, Pawar S. Development and validation of stability indicating RP-HPLC method for simultaneous determination of aspirin, rosuvastatin, clopidrogel in bulk and pharmaceutical dosage form. Int J Pharm Pharm Sci 2018;10:51-6.
16. Yulianita R, Sopyan I, Muchtaridi M. Forced degradation study of statins: A review. Int J Pharm Pharm Sci 2018;10:38-42.
17. Ramadan AZ, Mandil H, Ali RS. Spectrophotometric determination of rosuvastatin in pure form and pharmaceutical formulations through ion-pair complex formation using bromocresol green. Int J Pharm Pharm Sci 2015;7:191-8.
18. Ramadan AZ, Mandil H, Shelwahi N. Spectrophotometric determination of rosuvastatin calcium in pure form and pharmaceutical formulations by the oxidation using iodine and formation triiodide complex in acetonitrile. Int J Pharm Pharm Sci 2014;6:579-89.
19. Begum S, Basha SA, Shazia F. Formulation and in-vitro evaluation of mouth dissolving tablets of amlodipine and rosuvastatin. Int J Curr Pharm Res 2015;7:88-91.
20. Prabu SL, Suriyaprakash TN. Cleaning validation and its importance in pharmaceutical industry. Pharm Times 2010;42:21-4.
21. Fourman GL, Mullen MV, Elilly E. Cleaning validation acceptance limits for pharmaceutical manufacturing operations. Pharm Times 1993;17:54-60.
22. ICH: Q2B. Harmonized Tripartite Guidelines, Validation of analytical procedures: Methodology, IFPMA. Geneva: Proceedings of the International Conference on Harmonization; 1996.
23. ICH: Q2 [R1], Validation of Analytical Procedures: Text and Methodology; 2005.
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.