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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

Losartan, UV Spectroscopy, pH Meter.

Introduction

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DRUG PROFILE

Chemical Name –[2-butyl-5-chloro-3-[[4-[2-(2H-tetrazol-5-yl) phenyl] phenyl] methyl] imidazol-4-yl] methanol

Structure


       
            Pict1.jpg
       

    Molecular Formula - C22H23ClN6O

Brand Name- Losar-25

Relative Molecular Mass - 422.9 gram/moles

Solubility- Soluble in Water, Methanol.

Pka- 5.5

Pharmacology

Losartan is an angiotensin II receptor blocker used to treat hypertension,  diabetic nephropathy, and to reduce the risk of stroke. Losartan has a long duration of action as it is given once daily. Patients taking losartan should be regularly monitored for hypotension, renal function, and potassium levels.

EXPERIMENTAL WORK

MATERIALS AND INSTRUMENTS

Table 6.1: List of chemicals
       
            List of chemicals.png
       

Table 6.2: List of Equipment
       
            List of Equipment.png
       

    FORMULATION

 

Dosage Form –Tablet Brand Name – Losar-25

The Marketed Formulation Contain 25mg

RESULT AND DISCUSSION

Selection of Wavelength

Tablet powder equivalent to 10 mg of Losartan was dissolved in small quantity of diluent in a 10

mL volumetric flask and final volume was made up to 10 ml with same. Sonicated for 10 minutes. Then the absorbance of the solution (after suitable dilution) was measured at 208nm using UV/visible spectrophotometer (Lab India) against diluent as a blank.

Analysis of Marketed Formulation

 


       
            Analysis of Marketed Formulation .png
       

    

Validation of UV Method

Linearity and Range


       
            Validation of UV Method.png
       

   Linearity curve for Losartan


       
            Linearity curve for Losartan .png
       

    

Linear Regression Data for calibration curve


       
            Linear Regression Data for calibration curve .png
       

Precision

 

Intra – day precision studies.


       
            Intra – day precision studies..png
       

    Inter– Day precision parameter with % RSD

 

 

LOD & LOQ of Losartan


       
            LOD & LOQ of Losartan.png
       

    

 

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”, 5th Edition, 2005, Saunders College Publishing. Harcourt Brace College Publishers, p; 725-750
  2. A.H.Backett, J.B. Stanlake,” Practical Pharmaceutical Chemistry “4th edition, part II, CBS Publisher and Distributors, Delhi, 2001, p;255-280.
  3. Willard, “Instrumental Methods of Analysis “7th edition, CBS Publisher and Distributors, Delhi. P;514
  4. Chatwal GR, Sham KA, High performance liquid chromatography. In: Instrumental methods of chemical analysis. 5th 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; 3rd 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.

Reference

  1. Douglas A. Skoog, F. James Holler, Timothy A. Nieman, “Principles of Instrumental Analysis”, 5th Edition, 2005, Saunders College Publishing. Harcourt Brace College Publishers, p; 725-750
  2. A.H.Backett, J.B. Stanlake,” Practical Pharmaceutical Chemistry “4th edition, part II, CBS Publisher and Distributors, Delhi, 2001, p;255-280.
  3. Willard, “Instrumental Methods of Analysis “7th edition, CBS Publisher and Distributors, Delhi. P;514
  4. Chatwal GR, Sham KA, High performance liquid chromatography. In: Instrumental methods of chemical analysis. 5th 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; 3rd 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.

Photo
Pardeshi Jyotshana Gokul
Corresponding author

Matoshri Institute of pharmacy, Dhanore, Yeola

Photo
Sonawane Kalyani Amol
Co-author

Matoshri Institute of pharmacy, Dhanore, Yeola

Photo
Dashpute Sanket Narendra
Co-author

Matoshri Institute of pharmacy, Dhanore, Yeola

Photo
Wagh Sheetal Vilas
Co-author

Matoshri Institute of pharmacy, Dhanore, Yeola

Pardeshi J. G, Sonawane K.A, Dashpute S.N, Wagh S.V, Uv Method Of Development For Estimation Of Losartan In Bulk & Marketed Formulation, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 7, 1850-1854. https://doi.org/10.5281/zenodo.12819837

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