Abstract

Attempts were made to develope UV method for simultaneous estimation of losartan from tablet. the mobile phase methanol:water(70:30 ratio).pKa was found drug 5.5.pH of drug was found to be 3.Selection of wavelength found to 208nm.The linearity,accuracy,precision,range,LOD,LOQ was within the limit as specified by the ICH guidelines.Hence these method simple economic precise accurate and reproducible.

Keywords

Introduction

       
           
       
Table 6.1: List of chemicals

       
           
       
Table 6.2: List of Equipment

FORMULATION –

       
           
       
Validation of UV Method –

       
           
       
Linearity curve for Losartan

       
           
       
Precision –

       
           
       
Intra – Day precision parameter with % RSD

       
           
       
Inter– Day precision parameter with % RSD

       
           
       
 CONCLUSION

The simple spectrophotometric method for determination of Losartan has been developed and validated as per ICH guidelines. The developed method is found to be sensitive, accurate and reproducible and can be used for the routine quality control analysis of Losartan in bulk and pharmaceutical formulations. Attempts were made to develop spectrophotometric for estimation of Losartan. The spectrophotometric methods were developed for estimation. For the spectrophotometric methods, Methanol was used as solvent. The wavelength used for Losartan 208nm. The spectrophotometric methods were validated according to the ICH guidelines. The linearity, precisions, LOD, LOQ by the spectrophotometric method were within the limit as specified by the ICH guidelines. Hence the methods were found to be simple, accurate, precise, economic and reproducible. so the proposed methods can be used for the routine quality control analysis of Venlafaxine in bulk drug as well as in formulations.

REFERENCE

1. Douglas A. Skoog, F. James Holler, Timothy A. Nieman, “Principles of Instrumental Analysis”, 5^th Edition, 2005, Saunders College Publishing. Harcourt Brace College Publishers, p; 725-750
2. A.H.Backett, J.B. Stanlake,” Practical Pharmaceutical Chemistry “4^th edition, part II, CBS Publisher and Distributors, Delhi, 2001, p;255-280.
3. Willard, “Instrumental Methods of Analysis “7^th edition, CBS Publisher and Distributors, Delhi. P;514
4. Chatwal GR, Sham KA, High performance liquid chromatography. In: Instrumental methods of chemical analysis. 5^th ed. Mumbai: Himalaya Publishing house: 2002. P:2.626-2.636.
5. ISO/IEC 17025. International standard: General requirements for the competence of testing and calibration laboratories. Geneva, Switzerland (1999).
6. U.S. Food and Drug Adminstration. Technical Review Guide: Validation of Chromatographic Methods. Rockville, MD: Center for Drug Evaluation and Research (CDER) (1993).
7. Frank Settle. Handbook of Instrumental techniques for analytical chemistry. NJ: Prentice Hall PTR: 1997. P:17,19,56,57.
8. U.S. Food and Drug Administration. Industry Draft Guidance Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation (Aug.2000).
9. USP 32 – NF 27, General Chapter 1225, Validation of Compendial Methods, 2009.
10. USP 32 – NF 27, General Chapter 1226, Verification of Compendial Method, 2009.
11. Nash R.A,Wachter A.H. Pharmaceutical Process Validation; 3^rd edition, Vol; 129, Marcel Dekker, Inc 2003,542- 559
12. ICH; Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures, ICH- Q2A, 1995.
13. ICH Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: Methodology, ICH- Q2B, 1997.
14. ICH; Validation of analytical procedures Text and methodology. Q2(R1). Fed Regist 2005;
15. Rockville, Maryland, the United States Pharmacopeia 25/National Formulary 20, ch. 1225, The United States Pharmacopeia Convention, 2002 2256 – 2259 .
16. Stability testing of New Drug Substances and Products, International Conference on Harmonization (ICH), Geneva, 1993, Q1E
17. www.regulatory.com, Validation of assays and tests method for Pharmaceutical laboratory, by R.V. Sarrio and J. Silvestre, 2005 Conference on Hamonization (ICH), Geneva, 1993, Q1E
18. John W. Dolan, Stability indicating Assays, LCGC North America, Volume 4,2002, 346- 349.