SIMULTANEOUS SPECTROPHOTOMETRIC DETERMINATION OF DAPAGLIFLOZIN AND SAXAGLIPTIN IN FIXED DOSE COMBINATION (FDC) BY Q-ABSORBANCE RATIO METHOD

INDIAN DRUGS ◽  
2021 ◽  
Vol 57 (11) ◽  
pp. 63-75
Author(s):  
Gan Ee How ◽  
◽  
Venkata Subrahmanya Lokesh Bontha
Keyword(s):  
Uv Spectra ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Ratio Method ◽  
Isosbestic Point ◽  
Good Precision ◽  
Absorbance Ratio ◽  
Ich Guidelines ◽  
Dose Combination

A simple Q-absorbance ratio method have been developed for the determination of dapagliflozin (DAPA) and saxagliptin (SAXA) in fixed dose combination (FDC) using UV-Visible spectrophotometer. In this method, the UV spectra of DAPA and SAXA were overlaid to obtain wavelength at isosbestic point (λiso) of 217.6 nm and at absorption maximum (λmax) of DAPA at 224.2 nm, which are involved in the formation of Q-absorbance equation. Validation of method was done according to ICH guidelines. DAPA and SAXA obeyed Beers law in the concentration range of 2-25 µg/mL and 5-25 µg/mL, respectively. Good accuracy of method was determined by recovery studies and found to be in the range of 103.1-104.6% for DAPA and 97.7-102.4% for SAXA. This method has shown good precision (%RSD < 2.0). Statistical analysis like one-way ANOVA and student t-test were conducted and the reported method was accurate. This method was found to be simple, cheap, eco-friendly accurate and precise and can be used for routine analysis of DAPA and SAXA in FDC for testing regularly in manufacturing units.

Development and Validation of an HPLC Method for Simultaneous Determination of Rifampicin, Isoniazid, Pyrazinamide, and Ethambutol Hydrochloride in Pharmaceutical Formulations

2015 ◽  
Vol 98 (5) ◽  
pp. 1234-1239 ◽  
Author(s):  
Paula R Chellini ◽  
Eduardo B Lages ◽  
Pedro H C Franco ◽  
Fernando H A Nogueira ◽  
Isabela C César ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Combined Treatment ◽  
Pharmaceutical Formulations ◽  
Gradient Elution ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Array Detector ◽  
Equilibration Time ◽  
Dose Combination

Abstract Tuberculosis treatment consists of a fixed dose combination of rifampicin (RIF), isoniazid (INH), pyrazinamide (PYZ), and ethambutol hydrochloride (EMB). The combined treatment using various drugs is necessary for patient curing, without recrudescence, and for prevention of drug-resistant mutants, which may occur during treatment. An HPLC-diode array detector (DAD) method for the simultaneous determination of RIF, INH, PYZ, and EMB in fixed dose combination tablets was developed and validated. Chromatographic experiments were performed on an Agilent 1200 HPLC system, and the separation was carried out on a Purospher STAR RP18e (250 × 4.6 mm id, 5 μm, Merck) analytical column. Gradient elution was carried out with a mobile phase of 20 mM monobasic sodium phosphate buffer with 0.2% triethylamine (pH 7.0) and acetonitrile at a flow rate of 1.5 mL/min. The total run time was 12 min, and the re-equilibration time was 5 min. EMB detection was performed at 210 nm, and RIF, INH, and PYZ were detected at 238 nm, using a DAD. The method proved to be specific, linear (r2 &gt; 0.99), precise (RSD &lt;2%), accurate, and robust and may be applied to the QC analysis of pharmaceutical formulations.

NOVEL UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF SITAGLIPTIN PHOSPHATE AND SIMVASTATIN BY AREA UNDER CURVE METHOD

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (04) ◽  
pp. 46-52
Author(s):  
V. V. Chopde ◽  
◽  
P. M. Patil ◽  
S. D Rathod ◽  
P. D. Chaudhari
Keyword(s):  
Simultaneous Determination ◽  
Wavelength Range ◽  
Spectrophotometric Method ◽  
Area Under Curve ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Economic Method ◽  
Curve Method ◽  
Dose Combination

A simple, versatile, accurate, precise and economic method for simultaneous determination of sitagliptin phosphate and simvastatin in fixed dose combination products was developed. The absorbance values at 267 nm and 239 nm for sitagliptin phosphate and simvastatin. The combination is also estimated by AUC method it involved measurement of area under curve in the wavelength range is 264-270 nm (λ1 -λ2 ) and 236-242 nm (λ3 -λ4 ) sitagliptin phosphate and simvastatin respectively. This method obeyed Beer’s law in the concentration range of 10-60 μg /mL for sitagliptin phosphate and 2-12 μg /mL for simvastatin. The results of analyses have been validated statistically for linearity, accuracy, precision, LOD and LOQ of the proposed method.

scholarly journals DERIVATIVES OF THE RATIO SPECTRA FOR DETERMINATION OF ACETYLSALICYLIC ACID, ACETAMINOPHEN, AND CAFFEINE IN FIXED-DOSE COMBINATION FORMULATIONS: APPLICATION TO DISSOLUTION STUDIES

2020 ◽  
pp. 253-257
Author(s):  
JOSE RAUL MEDINA-LÓPEZ ◽  
JOSUE GIOVANI PACHECO PINEDA ◽  
PEDRO ALBERTO ROJAS GARFIAS ◽  
NICASIO CASTRO CHÁVEZ
Keyword(s):  
Drug Product ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Reference Drug ◽  
Zero Crossing ◽  
Dissolution Studies ◽  
Derivative Method ◽  
Dose Combination ◽  
Derivatives Of

Objective: To develop a ratio-derivative spectrophotometric method for the simultaneous quantification of acetilsalycilic acid (ASA), acetaminophen (ACE), and caffeine (CAF) in fixed-dose combination formulations. The proposed method was applied to the reference drug product Excedrin® in dissolution studies. Methods: The method is based on the use of the first-and second-derivatives of the ratio spectra and measurements at zero-crossing wavelengths. The dissolution profiles of ASA, ACE, and CAF were obtained following pharmacopeial conditions, USP Apparatus 2 at 100 rpm and 900 ml of water. Dissolution samples were treated with the proposed UV-derivative method and the results were compared with those obtained with a validated HPLC procedure. The dissolution efficiency was used to compare dissolution profiles (HPLC vs. UV-derivative method). Results: The method was linear in the range of 5-25 µg/ml of ASA, 2.5-20 µg/ml of ACE, and 1-8 µg/ml of CAF (R2>0.999, *P<0.05). The precision and accuracy of synthetic mixtures were within acceptable criteria (2.11-3.43% and 96.78-104.15%, respectively). Nitrocellulose filters were the best option to filter samples and stability of all drugs was adequate when standard solutions were stored at 4 °C during 24 h. No significant differences were found between dissolution profiles (*P>0.05). Conclusion: The proposed UV-derivative method allows the simultaneous determination of ASA, ACE, and CAF in commercial formulations. The method is simple, accurate, and precise and can be used in dissolution studies. Spectrophotometric methods are of low cost and harmless to the environment and, therefore, a better alternative than chromatographic methods.

Use of chemometrics to compare NIR and HPLC for the simultaneous determination of drug levels in fixed-dose combination tablets employed in tuberculosis treatment

2018 ◽  
Vol 149 ◽  
pp. 557-563 ◽  
Author(s):  
Kelly Sivocy Sampaio Teixeira ◽  
Said Gonçalves da Cruz Fonseca ◽  
Luís Carlos Brigido de Moura ◽  
Mario Luís Ribeiro de Moura ◽  
Márcia Herminia Pinheiro Borges ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Tuberculosis Treatment ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Drug Levels ◽  
Dose Combination

Development of a robust SFC method for evaluation of compatibility for a novel antituberculotic fixed-dose combination

2019 ◽  
Vol 11 (13) ◽  
pp. 1777-1787 ◽  
Author(s):  
Valentina Petruševska ◽  
Iva Krtalić ◽  
Andrea Rašić ◽  
Ana Mornar
Keyword(s):  
Simultaneous Determination ◽  
Supercritical Fluid ◽  
Supercritical Fluid Chromatography ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Chromatography Method ◽  
Dose Combination

A fast and simple supercritical fluid chromatography method for the simultaneous determination of two antituberculotic drugs, isoniazid and rifabutin, and their impurities from a new proposed fixed-dose combination (FDC) was developed.

Spectroscopic Determination of Aspirin and Omeprazole by Absorbance Ratio and Multicomponent Mode Method

2017 ◽  
Vol 10 (6) ◽  
pp. 3900-3905
Author(s):  
Hajera Khan ◽  
Swapna S Bandewar ◽  
Mohammad Zameeruddin ◽  
Vishvanath B Bharkad
Keyword(s):  
Accurate Method ◽  
Analysis Data ◽  
Spectroscopic Determination ◽  
Ratio Method ◽  
Analysis Method ◽  
Isobestic Point ◽  
Absorbance Ratio ◽  
Ich Guidelines ◽  
Mode Method

Here we describe a simple, rapid and accurate method for simultaneous assay of aspirin and omeprazole. The first method was Absorbance ratio method (Method 1) and second method was multi component mode method of analysis (Method 2).  Methanol: water (8:2) was used as solvent for both methods, using 293 nm as isobestic point for absorbance ratio method. The wavelength ranges 275.80 nm for aspirin and 302.20 nm for omeprazole for method 2, which represents the absorbance maxima of both drugs respectively. Beer’s law was applied in the concentration ranges of 2-14μg/mL and 2-18 μg/mL for aspirin and omeprazole, respectively, in absorbance ratio methods. The percentage assay was found to be in the range 99.74 to 100 % for aspirin and 99.69 to 99.9 % for omeprazole for both the methods. Recovery was found in the range of 99.74 –100.14 % for aspirin and omeprazole for both methods. The analysis data has been validated statistically and recovery studies confirmed the accuracy and reproducibility of the proposed methods, which were carried out according to the ICH guidelines.     

NEW SENSITIVE UV SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF ZIDOVUDINE AND LAMIVUDINE IN FIXED DOSE COMBINATION

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (03) ◽  
pp. 28-33
Author(s):  
A Chauhan ◽  
◽  
P.K Arora ◽  
R Nagpal ◽  
D Duggal ◽  
...  
Keyword(s):  
Wave Length ◽  
Estimation Method ◽  
Simultaneous Equation ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Dose Combination ◽  
Tablet Dosage

Two new, simple, accurate and sensitive UV spectrophotometric methods have been developed and subsequently validated for the simultaneous estimation of zidovudine and lamivudine in a fixed dose combination. Zidovudine and lamivudine have an absorption maxima at 267.3 nm and 272.3 nm respectively. The first method is based upon the simultaneous equation and second upon the determination of Q value. The simultaneous estimation method is based upon the measurements of ratios of absorptivity and absorbance, of both the components at their absorption maxima. The method of Q analysis is based on the measurement of ratios of absorptivity and absorbance, of both components at two selected wavelengths; one is an isoabsorptive point i.e. 270.1 nm and other being the wave length maxima of any of the two components, say λmax of zidovudine i.e. 267.3 nm. Both zidovudine and lamivudine shows linearity over the concentration range of 4-12 ppm at their respective absorption maxima and at isoabsorptive point. The assay and recovery studies from fixed dose combination as tablet dosage form are indicative of accuracy of the proposed methods. The developed methods were validated in accordance to International Conference on Harmonization (ICH) guidelines for linearity, range, accuracy and precision.

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