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Development and Validation of Derivative Spectrophotometric Method for Simultaneous Estimation of Levosulpiride and Esomeprazole in Capsule Dosage Form


Affiliations
1 Department of Pharmaceutical Analysis, Maliba Pharmacy College, Bardoli, Gujarat, India
2 Depatment of Quality Assurance, Maliba Pharmacy College, Bardoli, Gujarat, India
     

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The use of first order derivative spectrophotometry allows simultaneous determination of levosulpiride and esomeprazole in fixed dose combination products. The wavelengths 275 nm and 291.5 nm of first derivative spectrum were selected for the estimation of levosulpiride and esomeprazole, respectively without mutual interference. The method was linear in the concentration range 25-125 μg/ml and 5-25 μg/ml for levosulpiride and esomeprazole, respectively. The method was validated in terms of accuracy and precision. The result of the formulation analysis shows that the proposed method can be successfully used for the simultaneous estimation of both the drugs in their combined capsule dosage form.

Keywords

Levosulpiride, Esomeprazole, Ultra-violet spectrophotometry, Derivative spectrophotometry, Zero
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  • The Merck index, 14th Edn, Published by Merck research laboratories, Division of Merck and Co., INC., Whitehouse station, NJ, USA, 2006, 7014, 8989
  • Clarke’s analysis of Drugs and Poisons, 3rd Edn, Indian edition, K.M. Varghese Comesoy, Dadar, Mumbai, 2004, Volume 2, 1390,1594
  • Manjunath S, Chouhan V, Sandeep S, “Spectrophotometric estimation of levosulpiride in bulk drug and formulations”, International Journal of Pharmacy and Pharmaceutical Sciences, 2011, 3(2), 135-137
  • Manjunath S, Chouhan V, “Visible spectrophotometric estimation of levosulpiride in bulk drug and formulations”, Pharma Science Monitor: An International Journal of Pharmaceutical Sciences, 2012, 3(1), 139-145
  • Cho HY, Lee YB, “Improvement and validation of a liquid chromatographic method for the determination of levosulpiride in human serum and urine”, Journal of Chromatography B, 2003, 796, 243–251
  • Jin SE, Ban E, Kim YB, Kim CK, “Development of HPLC method for the determination of levosulpiride in human plasma”, Journal of Pharmaceutical and Biomedical Analysis, 2004, 35, 929–936
  • Padmalatha M, Snehalatha T, Ramya S, Kanakadurga M, “A simple and validated RP-HPLC method for the simultaneous estimation of Rabeprazole and Levosulpiride in bulk and pharmaceutical dosage forms”, International Research Journal of Pharmaceutical and Applied Sciences, 2012, 2(2), 99-106
  • Walash MI, El-din S, El-enany NM, “Simultaneous determination of Sulpiride and Mebeverine by HPLC method using fluorescence detection: application to real human plasma”, Chemistry Central Journal, 2012, 6, 13
  • Bano S, Mohd A and Siddiqi KS, “Development of spectrofluorimetric methods for the determination of levosulpiride in pharmaceutical formulation”, Journal of Analytical Chemistry, 2011, 66(7), 606-609
  • Gawande V, Chandewar R, “Spectroscopic estimation of esomeprazole magnesium in solid dosage form”, International Journal of Pharmacy and Technology, 2002, 2(3), 617-22
  • Patil S, Dhabale P, Kuchekar B, “Development and statistical validation of spectrophotometric method for estimation of esomeprazole in tablet dosage form”, Asian Journal of Research in Chemistry 2009, 2(2), 154-56
  • Sharmal M, Sharma S, “Spectrophotometric methods for the estimation of esomeprazole magnesium trihydrate in pharmaceutical formulations using indigo carmine reagent. International Journal of PharmTech Research, 2011, 3(2), 1186-90
  • Onal A, Oztunc A, “Development and validation of hplc method for the determination of esomeprazole in tablets”, Journal of Food and Drug Analysis, 2006, 14(1), 12-18
  • Rathi G, Singh R, Patel P, Kumar B, “RP-HPLC method for the estimation of esomeprazole magnesium in bulk and its pharmaceutical dosage form”, International Journal of Pharmaceutical Science and Research, 2010, 1(6), 75-80
  • Nalwade S, Reddy V, Rao D, “A validated stability indicating UPLC method for determination of impurities in esomeprazole magnesium gastro resistant tablets”, Journal of Pharmaceutical and Biomedical Analysis, 2011, 57, 109-14
  • Reddy P, Saita S, Vasudevmurthya G, Vishwanatha B, Prasada V, Reddy S, “Stability indicating simultaneous estimation of assay method for naproxen and esomeprazole in pharmaceutical formulations by RP-HPLC”, Scholars Research Library, 2011, 3(6), 553-64
  • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use, Validation of Analytical Procedures: Text and Methodology ICH Q2(R1), 2005

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  • Development and Validation of Derivative Spectrophotometric Method for Simultaneous Estimation of Levosulpiride and Esomeprazole in Capsule Dosage Form

Abstract Views: 421  |  PDF Views: 2

Authors

Brijen Vaghela
Department of Pharmaceutical Analysis, Maliba Pharmacy College, Bardoli, Gujarat, India
Gunjansinh Parmar
Depatment of Quality Assurance, Maliba Pharmacy College, Bardoli, Gujarat, India
Shailesh Shah
Depatment of Quality Assurance, Maliba Pharmacy College, Bardoli, Gujarat, India
Dinesh Shah
Depatment of Quality Assurance, Maliba Pharmacy College, Bardoli, Gujarat, India

Abstract


The use of first order derivative spectrophotometry allows simultaneous determination of levosulpiride and esomeprazole in fixed dose combination products. The wavelengths 275 nm and 291.5 nm of first derivative spectrum were selected for the estimation of levosulpiride and esomeprazole, respectively without mutual interference. The method was linear in the concentration range 25-125 μg/ml and 5-25 μg/ml for levosulpiride and esomeprazole, respectively. The method was validated in terms of accuracy and precision. The result of the formulation analysis shows that the proposed method can be successfully used for the simultaneous estimation of both the drugs in their combined capsule dosage form.

Keywords


Levosulpiride, Esomeprazole, Ultra-violet spectrophotometry, Derivative spectrophotometry, Zero

References