DEVELOPMENT AND VALIDATION OF UV SIMULTANEOUS EQUATION METHOD FOR DETERMINATION OF AZITHROMYCIN AND LEVOFLOXACIN IN BULK DRUGS AND MARKETED FORMULATION

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (11) ◽  
pp. 51-56
Author(s):  
S Kamepalli ◽  
◽  
J Pachipanta ◽  
A. K. Pathan ◽  
B. S. S. Naik
Keyword(s):  
Calibration Curve ◽  
Bacterial Infections ◽  
Uv Spectroscopy ◽  
Correlation Coefficients ◽  
Simultaneous Equation ◽  
Simultaneous Equations ◽  
Absorbance Maximum ◽  
Ich Guidelines ◽  
Development And Validation

Azithromycin and levofloxacin used for the treatment of bacterial infections. Simple, specific, accurate and precise UV spectroscopy method has been developed and validated for simultaneous determination of azithromycin and levofloxacin in bulk drugs and marketed formulation. The developed method involves solving of simultaneous equations using methanol as solvent where an absorbance maximum for azithromycin and levofloxacin was found to be at 291.92nm and 294.08nm, respectively. The drugs obeyed Beer’s law in the concentration range of 50- 250 μg/ mL & 2 – 10 μg/ mL. The method was validated as per ICH guidelines .The method showed good correlation coefficients (r2) 0.999, indicated good linearity of calibration curve for both the drugs. The recovery of azithromycin and levofloxacin was 98.82% and 97 .74% respectively. The robustness and ruggedness of azithromycin (0.368, 0.285), and levofloxacin (0.556, 0.442). The developed method was found to be accurate, reliable, robust showing LOD 0.012μg/mL and 0.016μg/mL LOQ 0.053μg/mL and 0.058μg/mL for azithromycin and levofloxacin.

scholarly journals Simultaneous determination of Propranolol hydrochloride and Hydrochlorothiazide in Tablets formulation using spectrophotometric technique (Simultaneous Equation Method)

2015 ◽  
Vol 1 (1) ◽  
pp. 45
Author(s):  
Bhadresh V Savaj ◽  
Hasumati A. Raj ◽  
Rajanit V Sojitra ◽  
Paras Virani
Keyword(s):  
Simultaneous Determination ◽  
Simultaneous Equation ◽  
Equation Method ◽  
Propranolol Hydrochloride ◽  
Data Manipulation ◽  
Ich Guidelines ◽  
Quality Control Testing ◽  
Minimal Data ◽  
Development And Validation

A new spectrophotometric method was developed for simultaneous determination of compounds with interfering spectra in binary mixtures without previous separation, showing significant advantages over the conventional methods regarding minimal data manipulation and applicability. The proposed method was applied for the determination of Propranolol hydrochloride and Hydrochlorothiazide in Tablets formulation, for determination of sampling wavelength, 10 ?g/ml of each of PRO and HCT were scanned in 200-400 nm range and sampling wavelengths were 289 nm for PRO and 270 nm for HCT are selected for development and validation of simultaneous equation method. For this method linearity observed in the range of 10-50 ?g/ml for PRP and 5-25 ?g/ml for HCT, and in their pharmaceutical formulation with mean percentage recoveries 100.13 0.86 and 100.07 0.58, respectively. The method was validated according to ICH guidelines and can be applied for routine quality control testing.

Development and Validation of HPTLC and Green HPLC Methods for Determination of a New Combination of Quinfamide and Mebendazole

2019 ◽  
Vol 58 (1) ◽  
pp. 16-21
Author(s):  
Ibrahim A Naguib ◽  
Eman S Hassan ◽  
Aml A Emam ◽  
Eglal A Abdelaleem
Keyword(s):  
Simultaneous Determination ◽  
Mobile Phase ◽  
Simultaneous Equation ◽  
New Combination ◽  
Chromatographic Methods ◽  
Ich Guidelines ◽  
Quality Control Testing ◽  
Significant Difference ◽  
Development And Validation

Abstract Two selective and sensitive chromatographic methods were developed for simultaneous determination of new combination of quinfamide and mebendazole in bulk powder and in pharmaceutical formulation. The first method is HPTLC by which separation was obtained using silica gel HPTLC F254 plates and a simple mobile phase consisting of methanol:toluene (2:6, v/v) and the separated bands were scanned at 254 nm. The second method RP-HPLC that comprised isocratic separation of both drugs on a Phenomenex C18 column using a green mobile phase consisting of double distilled water:methanol (30:70, v/v) at a flow rate of 0.8 mL/min and UV detection at 254 nm. The developed methods were validated and proved to meet ICH guidelines. Successful application of the developed methods was carried out for determination of quinfamide and mebendazole in Vermox Plus® tablets. Statistical comparison between the developed chromatographic methods and the reported simultaneous equation spectrophotometric method showed that there was no significant difference between them, proving the ability of applying the proposed methods in quality control testing of the studied drugs. The developed methods are considered the first chromatographic methods for simultaneous determination of quinfamide and mebendazole; moreover, they offered sensitive and selective eco-friendly methods for analysis of the studied drugs.

Development and Validation of Stability Indicating RP-HPLC Method for Determination of Enzalutamide

2019 ◽  
Vol 12 (5) ◽  
pp. 4635-4645
Author(s):  
Pankaj Padmakar Nerkar ◽  
Sameer Ansari ◽  
Shailesh Chalikwar
Keyword(s):  
Ammonium Acetate ◽  
Correlation Coefficients ◽  
Reversed Phase ◽  
Hplc Method ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation

A simple, isocratic, and accurate reversed phase HPLC method was developed for the quantitative determination of enzalutamide. The chromatographic separation was achieved on an Qualisil BDS C18 (250 mm x 4.6mm, 5 μm) column using methanol: ammonium acetate buffer pH 4.2 adjusted with glacial acetic acid: (60:40, v/v) as a mobile phase, at a flow rate of 1 ml/min and detection at 236nm. The linear range for enzalutamide were 2.0 to        10 μg/mL was obtained with correlation coefficients ≥ 0.998. The retention time was found to be 6.30min. Enzalutamide was subjected to stress conditions hydrolysis (acid, base) oxidation, photolysis and thermal degradation and the stressed samples were analysed by the developed method. The method was validated for the precision, accuracy, linearity and robustness. The developed stability indicating method for enzalutamide was validated as per ICH guidelines.

scholarly journals Development and validation of new analytical method for the simultaneous estimation of omeprazole and domperidone in pharmaceutical dosage form by UV spectrophotometry

2019 ◽  
Vol 1 (2) ◽  
pp. 44-46
Author(s):  
V. Pavan Kumar ◽  
C. Bhanu Chandra ◽  
N. Devendra ◽  
M. Kishor Kumar ◽  
S. Reddy Basha ◽  
...  
Keyword(s):  
Dosage Form ◽  
Simultaneous Equation ◽  
Dosage Forms ◽  
Simultaneous Estimation ◽  
Uv Spectrophotometry ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Ich Guidelines ◽  
Development And Validation

A simple, rapid and precise method was developed for the quantitative simultaneous determination of Omeprazole and Domperidone in combined pharmaceutical-dosage forms. The method was based on UV-Spectrophotometric determination of two drugs, using simultaneous equation method. It involves absorbance measurement at 291 nm (λmax of Omeprazole) and 289 nm (λmax of Domperidone) in Methanol: Acetonitrile (30:70 v/v). For UV Spectrophotometric method, linearity was obtained in concentration range of 1-15 µg/ml for Domperidone and 1-50 µg/ml for Omeprazole respectively, with regression 0.999 and 0.999 for Domperidone and Omeprazole respectively. Recovery was in the range of 99 -103%; the value of standard deviation and %R.S.D were found to be < 2 %; shows the high precision of the method., in accordance with ICH guidelines. The method has been successively applied to pharmaceutical formulation and was validated according to ICH guidelines.

Development and Validation of an Eco-Friendly and Low-Cost Method for the Quantification of Cefepime Hydrochloride in Powder for Injectable Solution Using Infrared (IR) Spectroscopy

2020 ◽  
Vol 16 (4) ◽  
pp. 456-464
Author(s):  
Danilo F. Rodrigues ◽  
Hérida R.N. Salgado
Keyword(s):  
Ir Spectroscopy ◽  
Low Cost ◽  
Pharmaceutical Preparations ◽  
Potassium Bromide ◽  
Pharmaceutical Products ◽  
Injectable Formulation ◽  
Ich Guidelines ◽  
Lactam Ring ◽  
Development And Validation

Background: A simple, eco-friendly and low-cost Infrared (IR) method was developed and validated for the analysis of Cefepime Hydrochloride (CEF) in injectable formulation. Different from some other methods, which employ organic solvents in the analyses, this technique does not use these types of solvents, removing large impacts on the environment and risks to operators. Objective: This study aimed at developing and validating a green analytical method using IR spectroscopy for the determination of CEF in pharmaceutical preparations. Methods: The method was validated according to ICH guidelines and the quantification of CEF was performed in the spectral region absorbed at 1815-1745 cm-1 (stretching of the carbonyl group of β- lactam ring). Results: The validated method showed to be linear (r = 0.9999) in the range of 0.2 to 0.6 mg/pellet of potassium bromide, as well as for the parameters of selectivity, precision, accuracy, robustness and Limits of Detection (LOD) and Quantification (LOQ), being able to quantify the CEF in pharmaceutical preparations. The CEF content obtained by the IR method was 103.86%. Conclusion: Thus, the method developed may be an alternative in the quality control of CEF sample in lyophilized powder for injectable solution, as it presented important characteristics in the determination of the pharmaceutical products, with low analysis time and a decrease in the generation of toxic wastes to the environment.

scholarly journals Simultaneous Estimation of Domperidone and Pantoprazole in Solid Dosage Form by UV Spectrophotometry

2006 ◽  
Vol 3 (3) ◽  
pp. 142-145
Author(s):  
P. Ravi Kumar ◽  
P. Bhanu Prakash ◽  
M. Murali Krishna ◽  
M. Santha Yadav ◽  
C. Asha Deepthi
Keyword(s):  
Simultaneous Equation ◽  
Simultaneous Equations ◽  
Simultaneous Estimation ◽  
Uv Spectrophotometry ◽  
Q Value ◽  
Value Analysis ◽  
Spectrophotometric Methods ◽  
Solid Dosage ◽  
Tablet Dosage

Domperidone is an antiemetic and pantoprazole is an antiulcer drug. Simple, precise, rapid and selective simultaneous equation and Q- analysis UV spectrophotometric methods have been developed for the simultaneous determination of domperidone and pantoprazole from combined tablet dosage forms. The methods involve solving of simultaneous equations and Q-value analysis based on measurement absorptivity at 216, 287 and 290 nm respectively. Linearity lies between 1-15 mcg/mL for domperidone and 0-50 mcg/mL for pantoprazole.

scholarly journals Development and validation of a gas chromatography method for the determination of β-caryophyllene in clove extract and its application

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mi Hee Park ◽  
Chul Jin Kim ◽  
Jin Young Lee ◽  
In Seon Kim ◽  
Sung-Kyu Kim
Keyword(s):  
Active Constituent ◽  
Chromatography Method ◽  
Ich Guidelines ◽  
Specificity Test ◽  
Detection Response ◽  
Standard Solution ◽  
Clove Extract ◽  
Pharmaceutical Uses ◽  
Development And Validation

AbstractThe purpose of this study is to check the effectiveness of the analysis method that separates and quantifies β-caryophyllene among clove extracts and validate according to current ICH guidelines. The β-caryophyllene was active constituent of clove buds. The developed method gave a good detection response. In the specificity test, the standard solution was detected at about 17.32 min, and the test solution was detected at 17.32 min. The linearity of β-caryophyllen was confirmed, and at this time, the correlation coefficient (R2) of the calibration curve showed a high linearity of 0.999 or more in the concentration range. The levels of LOD and LOQ were 1.28 ug/mL and 3.89 ug/mL, respectively. The accuracy was confirmed to be 101.6–102.2% and RSD 0.95 ~ 1.31%. As a result of checking the repeatability and inter-tester reproducibility to confirm the precision, the RSD was found to be 1.34 ~ 2.69%. This validated GC method was successfully applied to a soft capsule containing clove extract and other materials for clinical trials. Therefore, this method can be used as an analytical tool for quality control of various samples, including clove extracts and their products of food and pharmaceutical uses.

scholarly journals Newly Developed Highly Sensitive Method for the Determination of Capecitabine by Using UV-Spectroscopy

2019 ◽  
Vol 11 (03) ◽  
Author(s):  
Manas Ranjan Mishra ◽  
Punam Agrawal ◽  
Surya Narayan Das
Keyword(s):  
Colon Cancer ◽  
Uv Spectroscopy ◽  
First Line ◽  
Spectrophotometric Methods ◽  
Advanced Colon Cancer ◽  
Ich Guidelines ◽  
Highly Sensitive ◽  
Solvent Systems ◽  
Sensitive Method

Capecitabine is a 'pro-drug' to the cytotoxic agent 5-fluorouracil (5-FU) intended to administered orally. Capecitabine is generally used as first line monotherapy for advanced colon cancer. Simple, rapid, accurate UV spectrophotometric methods were developed in the present study and validated for the estimation of Capecitabine in bulk and its formulations as per ICH guidelines. Three solvent systems viz., 0.1N NaOH, 0.1N HCl and Methanol: Water (1:3) was tried. The results suggest that the developed method shows linearity over the range of concentration 2-24μg/ml and a correlation coefficient of 0.9999. Accuracy, precision, linearity, robustness, and ruggedness were statistically validated as per ICH guidelines for all the developed methods. The % RSD values for validated methods were found to be less than 1.5 and methods will find application in routine analysis of drug formulations containing Capecitabine.

DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF SELEGILINE HYDROCHLORIDE LOADED SOLID LIPID NANOPARTICLES

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (08) ◽  
pp. 57-60
Author(s):  
J. B Prajapati ◽  
H Rao ◽  
H Shah ◽  
Keyword(s):  
Correlation Coefficient ◽  
Spectrophotometric Method ◽  
Solid Lipid Nanoparticles ◽  
Lipid Nanoparticles ◽  
Laboratory Scale ◽  
Solid Lipid ◽  
Ich Guidelines ◽  
Development And Validation

The present paper discusses about a simple, precise and validated method for the determination of selegiline loaded solid lipid nanoparticles. The study was carried as per the parameters laid down in ICH guidelines. Maximum wavelength of selegiline in 8:2 methanol: chloroform mixture was selected at 258nm. The method was found to be linear in the range of 200μg/mL to 1000μg/mL with correlation coefficient R2 of 0.994. Method was successfully validating as per ICH guidelines. Moreover, this method was simple, sensitive and easy to apply and can be performed at laboratory scale. Hence, the proposed method can be used for analysis of determination of selegiline loaded solid lipid nanoparticles.

SIMULTANEOUS ESTIMATION AND VALIDATION OF RAMIPRIL AND TELMISARTAN BY UV SPECTROPHOTOMETRY

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (09) ◽  
pp. 31-35
Author(s):  
R Rambabu ◽  
◽  
S Vidyadhara ◽  
J Subbarao
Keyword(s):  
Spectrophotometric Method ◽  
Correlation Coefficients ◽  
Simultaneous Equation ◽  
Dosage Forms ◽  
Simultaneous Estimation ◽  
Uv Spectrophotometry ◽  
Intermediate Precision ◽  
Pharmaceutical Dosage Forms ◽  
Sensitive Spectrophotometric Method

A simple and sensitive spectrophotometric method for the determination of ramipril and telmisartan in pharmaceutical dosage forms has been developed. The absorption maxima were found at 220nm for ramipril and 297nm for telmisartan using 0.1N NaOH as solvent. Beer’s law was obeyed for both the drugs in the concentration range of 2-10μg/ml with correlation coefficients 0.999 for both ramipril and telmisartan. The limits of detection for ramipril and telmisartan were found to be 0.142 and 0.405μg/mL respectively and the limits of quantitation were 0.43 and 1.22μg/mL. Accuracy of the method was verified by performing recovery studies using simultaneous equation method and found to be 98.33 to 99.54%w/w for ramipril and 99.36 to 99.82 %w/w for telmisartan. %RSD of repeatability and intermediate precision studies were found to be <2 for both the drugs. Ruggedness of the method was checked by changing analyst worked and instrument used. In both the cases, the %RSD was found to be less than 2.

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