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Swapnil D. Jadhav ¹, Akshay A. Magdum ¹, Ramchandra M. Panchal ¹, Pradip S. Koli ¹

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

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

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Swapnil D. Jadhav ¹, Sharad C. Sarak ¹, Tushar S. Nimbalkar ¹, Manish S. Bhatia ¹, Harinath N. More ¹

Affiliations
1 Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur – 416 013, M. S., IN

Abstract

The Tenofovir Disoproxil, Ferrous, Bisoprolol and Ketotifen were used in marketed formulations in the form of fumaric acid salt due to stability and solubility purposes. Stability of marketed formulation is an important aspect that needs special attention over the period of time. Designing of colorimetric reagent (3, 5 Dinitro Benzoic Acid) and development of analytical method has been carried out for estimation of fumaric acid from marketed formulations which indirectly quantifies Bisoprolol and Ketotifen. The fumaric acid shows linearity in concentration range of 100- 700 ng/mL. The result of analysis of marketed formulation of Bisoprolol and Ketotifen we found to be within 98.00 to 102 % with RSD value of less than 2 %. The forced degradation studies of Bisoprolol and Ketotifen was carried out which shows degradation less than 20 % and results were accurate and precise. The method was validated using ICH Q2B (R1) guidelines. The method was found to be simple, accurate, precise, sensitive and selective.

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Mukta D. Naykode ¹, Durgacharan A. Bhagwat ¹, Swapnil D. Jadhav ², Harinath N. More ²

Affiliations
1 Department of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur-416013, M. S., IN
2 Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur-416013, M. S., IN

Abstract

A simple, specific and accurate reverse phase liquid chromatographic method was developed for determination of Azilsartan in its tablet dosage form as well as from biological fluid like plasma. The determination was carried out on ODS Hypersil C18 column (4.6 mm x 250 mm 5μm) column using a mobile phase of acetonitrile: water (pH 4) [60: 40 %v/v]. The flow rate was 1 mL/min with detection at 249 nm. The linearity response of the HPLC system for Azilsartan was obtained over the range 1-64 μg/mL. Ambroxol (25μg/mL) was used as internal standard. Retention time for Azilsartan and ambroxol were found to be 3.74 and 1.84 minutes respectively. The correlation co-efficient (R² value) for Azilsartan was found to be 0.992. The proposed method was successfully used for quantification of Azilsartan in Azilva tablets and plasma. The method was validated as per ICH Q2B (Analytical) and USFDA (Bio-analytical) guidelines. The results of analysis have been validated statistically and by recovery studies. The method is found useful for quantification of Azilsartan in marketed formulations as well as from biological fluids and can be applied for quantification of Azilsartan in preclinical and clinical studies.

Keywords

Azilsartan, Ambroxol, RP-HPLC, Plasma, ICH Q2B, Bioanalytical Method.

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Mukta D. Naykode ¹, Durgacharan A. Bhagwat ¹, Swapnil D. Jadhav ², Harinath N. More ²

Affiliations
1 Department of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur-416013, M. S., IN
2 Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur-416013, M. S., IN

Abstract

A simple, specific and accurate reverse phase liquid chromatographic method was developed for determination of Azilsartan in its tablet dosage form as well as from biological fluid like plasma. The determination was carried out on ODS Hypersil C18 column (4.6 mm x 250 mm 5μm) column using a mobile phase of acetonitrile: water (pH 4) [60: 40 %v/v]. The flow rate was 1 mL/min with detection at 249 nm. The linearity response of the HPLC system for Azilsartan was obtained over the range 1-64 μg/mL. Ambroxol (25μg/mL) was used as internal standard. Retention time for Azilsartan and ambroxol were found to be 3.74 and 1.84 minutes respectively. The correlation co-efficient (R² value) for Azilsartan was found to be 0.992. The proposed method was successfully used for quantification of Azilsartan in Azilva tablets and plasma. The method was validated as per ICH Q2B (Analytical) and USFDA (Bio-analytical) guidelines. The results of analysis have been validated statistically and by recovery studies. The method is found useful for quantification of Azilsartan in marketed formulations as well as from biological fluids and can be applied for quantification of Azilsartan in preclinical and clinical studies.

Keywords

Azilsartan, Ambroxol, RP-HPLC, Plasma, ICH Q2B, Bioanalytical Method.

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