Tejaswini Rajaram Mandale, Manish. S. Kondawar, Sandeep Dilip Kadam
Miss. Tejaswini Rajaram Mandale1*, Dr. Manish. S. Kondawar2, Mr. Sandeep Dilip Kadam3
1,3Department of Quality Assurance, ABCP, Sangli - 416416, Maharashtra, India.
2Head of Department of Quality Assurance, ABCP, Sangli - 416416, Maharashtra, India.
Volume - 13,
Issue - 9,
Year - 2020
A simple, rapid and reliable UV spectroscopic method was developed and validated for simultaneous estimation of Amlodipine besylate (Amlo) and Celecoxib (Celo) in pure and combined dosage form. Amlo and Celo shows absorption maximum in methanol at 237nm and 252nm respectively. According to ICH guidelines, this method was validated for linearity, precision, accuracy, limit of detection and Limit of quantitation. This method showed linearity and correlation coefficient for Amlo and Celo as 2 to 12µg/ml, 0.9981 and 0.9984 respectively. The recovery studies for Amlo and Celo was obtained to be 100.5 to 101.66% and 100.28% to 101% respectively. The precision of method were established by repeatability study. Limit of detection and Limit of quantitation are 0.21µg/ml and 0.64µg/ml for Amlo and 0.12µg/ml and 0.36µg/ml for Celo respectively. The statistical parameters and recovery data presented that the method may be engaged for efficient, rapid examination of both drugs the from tablet formulation. The percentage label claim present in formulation tablet was obtained to be 99% and 100.3% for Amlo and Celo respectively. These analysis is clearly specified that without there interference from excipients in the formulation.
Cite this article:
Tejaswini Rajaram Mandale, Manish. S. Kondawar, Sandeep Dilip Kadam. Development and Validation of Analytical Method for Simultaneous Estimation of Amlodipine Besylate and Celecoxib in Pure and Combined Dosage Form. Research J. Pharm. and Tech 2020; 13(9):4280-4284. doi: 10.5958/0974-360X.2020.00756.8
Tejaswini Rajaram Mandale, Manish. S. Kondawar, Sandeep Dilip Kadam. Development and Validation of Analytical Method for Simultaneous Estimation of Amlodipine Besylate and Celecoxib in Pure and Combined Dosage Form. Research J. Pharm. and Tech 2020; 13(9):4280-4284. doi: 10.5958/0974-360X.2020.00756.8 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-9-44
1. Logoyda Liliya, Korobko Dmutro and Saprun Stanishav, “Development of methods for identification of calcium channel blockers in medicine”, International Journal of research Ayurveda pharm, 2016; 7(2): 88-91.
2. Indian Pharmacopoeia 2007, Vol I and II, 143 and 96-97
3. Primo Fabián Teixeira and Pedro E. Froehlich, “Celecoxib Identification Methods”, Acta Farm. Bonaerense, 2005; 24 (3): 421-425.
4. Naveed Safila., Qamar Hina, Jawaid Wardha, and Bokhariet Urooj, “Simple UV spectrophotometric assay of amlodipine”, American Journal of Chemistry and application, 2014; 1(4): 66-69.
5. Saha R. N. Sajeev C., Jadhav P.R., Patil S.P., and Srinivasan N., “Determination of celecoxib in Pharmaceutical formulations using UV spectrophotometry and liquid chromatography”, Journal of pharmaceutical and Biomedical analysis, 2002; 28: 741-751.
6. Vichare Vijaya., Vrushali Tambe, Vrushali Kashikar And Dhole S.N, “Spectrophotometric simultaneous determination of amlodipine besylate and hydrochlorothiazide in combined tablet dosage form by simultaneous equation, absorption ratio and first order derivative spectroscopy methods”, International Journal of chemistry Research,2011; 2(1): 7-10.
7. Ingale. Pramod. L., Patil Laxmileena D., Gudi Sachin V., Jadav Deepali D., Kadam Yogita A. and Sampada D. Dalvi and “Development and validation of UV-spectrophotometric methods for simultaneous estimation of amlodipine besylate and clopidogrel bisulfate in bulk and tablet dosage form”, Der Pharma Chemica, 2013, 5 (4):282-287.
8. Jain P. S., Patel M. K., Bari S. B. and Surana S. J., “Development and Validation of HPTLC Method for Simultaneous Determination of Amlodipine Besylate and Metoprolol Succinate in Bulk and Tablets”, Indian Journal of Pharmaceutical Sciences, 2012; 74 (2): 152-156.
9. Patel V. B., Sahu Rajnikanta, and Patel Bhumika M, “Simultaneous determination of Amlodipine besylate and Atorvastatin calcium in Pharmaceutical tablet formulation by High Performance Thin Layer Chromatographic method”, International Journal of ChemTech Research, 2011; 3(2): 695-698.
10. Shaalan R. A., Belal Tarek S., El Yazbi Fawzy A. and Elonsy Sohila M., “Validated HPTLC methods for determination of some selected antihypertensive mixtures in their combined dosage forms”, Bulletin of Faculty of Pharmacy, Cairo University, 2014; 52: 225–237.
11. Kamble Asmita Y., Mahadik Mahadeo V., Khatal Laxman D. and Dhaneshwar Sunil R., “Validated HPLC and HPTLC Method for Simultaneous Quantitation of Amlodipine Besylate and Olmesartan Medoxomil in bulk drug and formulation”, Analytical Letters, 2010; 43(2): 251-258.
12. Chandana OSS and Ravichandrababu R., “Stability indicating HPLC method for celecoxib related substances in solid dosage forms”, International Journal of Research in Pharmacy and Science , 2017; 7(1): 10-18.
13. Jadhav Priyanka S., Jamakar Priti M. and Avachat Amelia M., “Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC”, Brazilian Journal of Pharmaceutical sciences, 2015; 51 (3).
14. Chanudhary Jasmine, Jain Akash and Vipin Saini, “Simultaneous estimation of multicomponent formulations by UV-Visible Spectroscopy: on Overview”, International research Journal of Pharmacy, 2011; 2(12): 81-83.
15. Kamal Amir, El-Malla Samah F. and Hammad Sherin F., “A Review on UV Spectrophotometric Methods for Simultaneous Multicomponent Analysis”, European Journal of Pharmaceutical and Medical Research, 2016; 3(2): 348-360.
16. Redasani K. V. Patel P. R., Marathe D. Y., Chudhari S. R., Shrikhedkar A. A. and Surna S.J., “ A review Derivative of UV spectrophotometry analysis of drugs in pharmaceutical formulation and biological samples review”, Journal of the Chilean Chemical society, 2018; 63 (3).