Asian Journal of Pharmaceutical Analysis

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Simultaneous Estimation of Metformin Hydrochloride and Rosiglitazone Maleate from Tablet Dosage Form by Derivative Spectroscopic Method


Affiliations
1 Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur – 416013, India
     

   Subscribe/Renew Journal


Metformin HCl (MET) and Rosiglitazone Maleate (ROS) are used in combination for treatment of diabetes as both drugs are oral hypoglycemic gents. The present work deals with simple derivative spectrophotometric method development for simultaneous estimation of MET and ROS in tablet formulation (AVANDAMET). For determination of sampling wavelength, 10 μg/ml of each of MET and ROS were scanned on UV-630 double beam spectrophotometer in 200-400 nm range. The estimation of ROS was carried out at 312 nm in zero order mode where MET showed zero crossing point and MET was estimated at 247 nm in first order mode where ROS showed zero crossing point. The marketed tablet formulation contains 500 mg of MET and 4 mg of ROS. Hence for analysis of ROS, standard addition of 100 mg of pure drug is carried out. For this method, linearity was observed in range of 10-90 μg/ml for MET and 2-18 μg/ml for ROS. The method is validated as per ICH guidelines. The recovery studies confirmed accuracy of proposed method and low values of standard deviation confirmed precision of method. The proposed method can be optimized further for the simultaneous estimation of both drugs from biological fluids, used in pharmacokinetic and bioequivalence studies.

Keywords

Derivative Spectroscopy, First Order, Zero Order, Metformin, Rosiglitazone
Subscription Login to verify subscription
User
Notifications
Font Size


  • Government of India, Ministry of Health and Family Welfare. Indian Pharmacopoeia. 1996; 4th Ed: Vol II, pp. 469-470.

  • Government of India, Ministry of Health and Family Welfare. Indian Pharmacopoeia. 1996; 4th Ed: Vol II, pp. 1674-1676.

  • Dadhania KP, Nadpara PA and Agrawal YK. Development and validation of spectrophotometric method for simultaneous estimation of gliclazide and metformin hydrochloride in bulk and tablet dosage form by simultaneous equation method. International Journal of Pharmaceutical Sciences and Research. 2(6); 2011: 1559-1563.

  • Doredla NR, Shanmugasundaram P and Vaishnav H. Method development and validated of simultaneous estimation of metformin hydrochloride, pioglitazone hydrochloride and glibenclamide in pure and tablet dosage form by spectrophotometric multi component method. International Journal of ChemTech Research. 4; 2011: 2011-2017.

  • Dhabale PN and Seeri CR. Simultaneous UV spectrophotometric method for estimation of gliclazide and metformin hydrochloride in tablet dosage form. International Journal of ChemTech Research. 2(2); 2010: 813-817.

  • Dadhania KP, Nadpura PA and Agrawal YK. Development and validation of spectrophotometric method for simultaneous estimation of gliclazide and metformin hydrochloride in bulk and tablet dosage form by simultaneous equation method. International Journal of Pharmaceutical Sciences and Research. 2(6); 2011:1559-1563.

  • Havele S and Dhaneshwar S. Development and validation of a HPLC method for the determination of metformin hydrochloride, gliclazide and pioglitazone hydrochloride in multicomponent formulation. Webmedcentral Pharmaceutical Sciences. 1(10); 2010:12-15.

  • Gumieniczek A, Berecka A, Hopkala H. et al. Rapid HPTLC determination of rosiglitazone in pharmaceutical formulations. Journal of Liquid Chromatography and Related Technology. 26(19); 2003: 3307–3314.

  • Gomes P, Sippel J, Jablonski A. et al., Determination of rosiglitazone in coated tablets by MEKC and HPLC methods. Journal of Pharmaceutical and Biomedical Analysis. 36; 2004: 909–913.

  • Radhakrishna T, Satyanarayana J and Satyanarayana A. LC determination of rosiglitazone in bulk and pharmaceutical formulation. Journal of Pharmaceutical and Biomedical Analysis. 29; 2002: 873–880.

  • Kolte BL, Raut BB, Deo AA. et al. Liquid chromatographic method for the determination of rosiglitazone in human plasma. Journal of Chromatography B. 788; 2003: 37–44.

  • Dhole SM, Khedekar PB and Amnerkar ND. Application of UV spectrophotometric and HPLC methods for simultaneous determination of rosiglitazone maleate and gliclazide in combined tablet dosage form International Journal of Pharmaceutical Chemistry Research, 1(1); 2012: 39-48.

  • Kolte BL, Raut BB, Deo AA. et al. Simultaneous determination of metformin in combination with rosiglitazone by reversedphase liquid chromatography. Journal of Chromatographic Science, 42; 2004: 70-73.

  • Havaldar FH and Vairal DL. Simultaneous estimation of metformin hydrochloride, rosiglitazone and pioglitazone hydrochloride in the tablet dosage form. International Journal of Applied Biology and Pharmaceutical Technology, 1 (3); 2010: 1000-1005.

  • International Conference on Harmonization. Draft revised guidance on validation of analytical procedures: methodology. Federal Register. Q2B (R1), 2000, 1-10..


Abstract Views: 1343

PDF Views: 0




  • Simultaneous Estimation of Metformin Hydrochloride and Rosiglitazone Maleate from Tablet Dosage Form by Derivative Spectroscopic Method

Abstract Views: 1343  |  PDF Views: 0

Authors

Swapnil D. Jadhav
Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur – 416013, India
Akshay A. Magdum
Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur – 416013, India
Ramchandra M. Panchal
Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur – 416013, India
Pradip S. Koli
Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur – 416013, India

Abstract


Metformin HCl (MET) and Rosiglitazone Maleate (ROS) are used in combination for treatment of diabetes as both drugs are oral hypoglycemic gents. The present work deals with simple derivative spectrophotometric method development for simultaneous estimation of MET and ROS in tablet formulation (AVANDAMET). For determination of sampling wavelength, 10 μg/ml of each of MET and ROS were scanned on UV-630 double beam spectrophotometer in 200-400 nm range. The estimation of ROS was carried out at 312 nm in zero order mode where MET showed zero crossing point and MET was estimated at 247 nm in first order mode where ROS showed zero crossing point. The marketed tablet formulation contains 500 mg of MET and 4 mg of ROS. Hence for analysis of ROS, standard addition of 100 mg of pure drug is carried out. For this method, linearity was observed in range of 10-90 μg/ml for MET and 2-18 μg/ml for ROS. The method is validated as per ICH guidelines. The recovery studies confirmed accuracy of proposed method and low values of standard deviation confirmed precision of method. The proposed method can be optimized further for the simultaneous estimation of both drugs from biological fluids, used in pharmacokinetic and bioequivalence studies.

Keywords


Derivative Spectroscopy, First Order, Zero Order, Metformin, Rosiglitazone

References