scholarly journals APPLICATION AND VALIDATION OF DERIVATIVE SPECTROPHOTOMETRIC FOR DETERMINATION LEVELS OF TERNARY MIXTURES OF PARACETAMOL, PROPYPHENAZONE, AND CAFFEINE IN TABLET DOSAGE FORM

2018 ◽  
Vol 11 (13) ◽  
pp. 8
Author(s):  
Artha Yuliana Sianipar ◽  
Muchlisyam Muchlisyam ◽  
Siti Morin Sinaga
Keyword(s):  
Spectrophotometric Method ◽  
Phosphate Buffer ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Ternary Mixtures ◽  
Limit Of Quantification ◽  
Zero Crossing ◽  
Validation Parameters ◽  
Tablet Dosage ◽  
Third Derivative

 Objective: This study was to develop a spectrophotometric method with derivative zero-crossing for determines the levels of paracetamol (PCT), propyphenazone (PRO), and caffeine (CAF) in tablet dosage form without prior separation.Method: The study begins with optimizing the type of solvent, phosphate buffer (pH 7.2) and a mixture of phosphate buffer (pH 7.2) with methanol at ratio 90:10; 70:30; 50:50; 30:70; and 10:90. Spectrophotometric method with zero-crossing, tested validity based on linearity, accuracy, precision, limit of detection, and limit of quantification. Then, the method applied to determine the levels of PCT, PRO, and CAF in tablet.Result: The mixture of phosphate buffer (pH 7.2) with methanol at ratio 70:30 can be used for analysis. Applications zero-crossing technique on assay of PCT and CAF performed on the first derivative and Δλ 2 with λ 239.4 nm for PCT and Δλ 8 with λ 245.6 nm for CAF while PRO in the third derivative and Δλ 8 with λ 249.6 nm, resulting 100.91%, 104.75%, and 103.33% for levels of PCT, PRO, and CAF, respectively.Conclusion: Spectrophotometric derivative method with zero-crossing qualified in validation parameters.

scholarly journals Spectrophotometric Method Development and Validation for Simultaneous Estimation of Nebivolol hydrochloride and Valsartan in Bulk and Combined Pharmaceutical Dosage Form in Release Media

2019 ◽  
Vol 11 (06) ◽  
Author(s):  
Chandani Makvana ◽  
Satyajit Sahoo
Keyword(s):  
Spectrophotometric Method ◽  
Phosphate Buffer ◽  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Limit Of Quantitation ◽  
Nebivolol Hydrochloride ◽  
Tablet Dosage

A simple, rapid, precise, accurate and sensitive spectrophotometric method has been developed for the simultaneous estimation and validation of Nebivolol Hydrochloride (NEB) and Valsartan (VAL) in pure and combined tablet dosage forms. Pure drug samples of NEB and VAL were dissolved in 67 mM Phosphate buffer pH 6.8 with 0.5% sodium dodecyl sulphate (SDS) and found to have absorbance maxima at 280 nm for NEB and 250 nm for VAL, respectively. The linearity lies between 10-70μg/ml for NEB and 10-60μg/ml for VAL in this method. The correlation coefficient (r2) was found to be 0.9965 for NEB and 0.9960 for VAL. The % recoveries obtained were 95.65%-109.85% for NEB and 97.42%-101.43% for VAL. The % RSD found 0.271%-1.490% for intraday and 0.334%-1.917% for interday for NEB and 0.188%-0.944% for intraday and 0.392%-1.197% for interday for VAL. The limit of detection and limit of quantitation for NEB were found to be 4.608μg/ml and 13.965μg/ml respectively and the limit of detection and limit of quantitation for VAL were found to be 4.348μg/ml and 13.178μg/ml respectively. Simultaneous calibration of both drugs in 67 mM Phosphate buffer pH 6.8 with 0.5% SDS shows that λmax of one drug does not interfere on the λmax of other drug. Recovery study was performed to confirm the accuracy of the method. The results of analysis have been validated statistically by recovery studies as per International Conference on Harmonization guidelines. The method showed good reproducibility and recovery with % RSD Lessthan 2. Hence, this proposed method was found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis of NEB and VAL in pure and combined tablet dosage form.

IR QUANTIFICATION OF MODAFINIL IN BULK AND ORAL DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (10) ◽  
pp. 63-65
Author(s):  
A. M Sekar ◽  
◽  
S Anbazhagan ◽  
R Agalya ◽  
T. Asha ◽  
...  
Keyword(s):  
Correlation Coefficient ◽  
Spectrophotometric Method ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Oral Dosage ◽  
Limit Of Quantification ◽  
Oral Dosage Form ◽  
Precision And Accuracy ◽  
Bulk Drug ◽  
Tablet Dosage

Simple and sensitive infrared spectrophotometric method has been developed for the estimation of modafinil in tablet dosage form and the Beer’s Law concentration range was found to be 1.0mg to 2.5mg. The correlation coefficient for the method was found to be 0.999 and the developed method was analyzed for specificity, limit of detection (LOD), limit of quantification (LOQ), linearity of response, precision and accuracy; thus the proposed method could be adopted for routine analysis of bulk drug and its formulation.

Method Development and Validation of Spectrophotometric Methods for The Estimation of Rizatriptan Benzoate in Pure and Pharmaceutical Dosage Form

2021 ◽  
pp. 6003-6006
Author(s):  
Pushpa Latha E. ◽  
Sailaja B.
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Rizatriptan Benzoate ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

Analytical UV derivative spectrophotometric method was developed and validated to quantify Rizatriptan Benzoate in pure drug and tablet dosage form. Based on the spectrophotometric characteristics of Rizatriptan Benzoate, a signal of zero (225nm), first (216nm), second (237nm), third (233nm), fourth (231nm) order derivative spectra were found to be adequate for quantification. The methods obeyed Beer's law in the concentration range of (0.1-360µg/ml) with square correlation coefficient (r2) of 0.999. The mean percentage recovery was found to be 100.01 ± 0.075. As per ICH guidelines the results of the analysis were validated in terms of linearity, precision, accuracy, limit of detection and limit of quantification, and were found to be satisfactory.

scholarly journals Application of RP-HPLC for the Estimation of Allopurinol and Its Related Substances in Bulk and Tablet Dosage Form

2021 ◽  
pp. 11-20
Author(s):  
Ch. Jaswanth Kumar ◽  
Prachet Pinnamaneni ◽  
Siva Prasad Morla ◽  
K. N. Rajini Kanth ◽  
Rama Rao Nadendla
Keyword(s):  
Drug Testing ◽  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Limit Of Quantification ◽  
Related Substance ◽  
Related Substances ◽  
Rp Hplc ◽  
Relative Standard ◽  
Tablet Dosage

Aims: The main aim of the present study was to develop and validate a simple and cost- effective method for the estimation of allopurinol and its related substances by using RP-HPLC. Study Design:  Estimation of Allopurinol and its related substance in bulk and tablet dosage forms by RP-HPLC. Place and Duration of Study: Chalapathi Drug Testing Laboratory, Chalapathi Institute of Pharmaceutical Sciences, Chalapathi Nagar, Lam, Guntur-522034 between October 2020 to January 2021. Methodology: Method development was carried out by using Schimadzu, Prominence-i series LC 3D-Plus autosampler embedded with lab solutions software, equipped with PDA detector using YMC column (150 mm X 4.6 mm, 3 μm) and 0.1M Ammonium acetate buffer as a mobile phase in the ratio of 100% at a flow rate of 1.0 ml/min at a wavelength of 255nm. The developed method was validated according to ICH guidelines. Results:  The linearity was observed in the range of 20-100 µg/ml with a regression (R2) value of 0.999. Developed method was specific with no interactions and accurate with 100.11% for allopurinol and 99.54% for its related substance. The limit of detection for allopurinol was 2 µg/ml and for related substance was 0.0.1 µg/ml. The limit of quantification for allopurinol was 6 µg/ml and for related substance was 0.03 µg/ml respectively. The percentage relative standard deviation was found to be NMT 2 which indicates that the proposed method was precise and robust. Conclusion:  The developed method was simple, precise and accurate and can be successfully employed for the estimation of allopurinol in bulk and tablet dosage form.

scholarly journals Development of the UV Spectrophotometric Method of Azithromycin in API and Stress Degradation Studies

2016 ◽  
Vol 68 ◽  
pp. 48-53 ◽  
Author(s):  
Sandip Bhimani ◽  
Gaurav Sanghvi ◽  
Trupesh Pethani ◽  
Gaurav Dave ◽  
Vishal Airao ◽  
...  
Keyword(s):  
Linear Relationship ◽  
Spectrophotometric Method ◽  
Phosphate Buffer ◽  
Macrolide Antibiotic ◽  
Limit Of Detection ◽  
High Sensitivity ◽  
Limit Of Quantification ◽  
Absorbance Maximum ◽  
Antibiotic Drug ◽  
Stress Degradation

Azithromycin (AZI) is a semi-synthetic macrolide antibiotic drug, effective against a wide variety of bacteria. The present study describes a simple, accurate, reproducible and precise UV Spectrophotometric method for the estimation of AZI (pH 6.8 Phosphate buffer). The absorbance maximum (λmax) for AZI was found to be 208nm. The method reveals high sensitivity, with linearity in the 10 µg/ml to 50 µg/ml range. The lower limit of detection was found to be 1.6µg/ml and the limit of quantification was found to be 5µg/ml. All the calibration curves demonstrated a linear relationship between the absorbance and concentration, with the correlation coefficient higher than 0.99. The % recovery was found to be 99.72%. AZI was also subjected to stress degradation under different conditions recommended by the International Conference on Harmonization (ICH).

scholarly journals NOVEL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TELMISARTAN AND NEBIVOLOL HCL IN PHARMACEUTICAL DOSAGE FORM

2018 ◽  
Vol 11 (9) ◽  
pp. 431 ◽  
Author(s):  
Heena Ar Shaikh ◽  
Vandana Jain
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Validation Parameters ◽  
Hplc Method Development

Objective: A simple, accurate, precise, robust reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the estimation of telmisartan and nebivolol hydrochloride (HCl) simultaneously in its combined dosage form.Methods: The compounds were well resolved in an isocratic method using the mobile phase composition of acetonitrile: Buffer (potassium dihydrogen orthophosphate pH adjusted 3.1 with orthophosphoric acid) in a ratio of 40:60 v/v at a flow rate of 1.2 ml/min using C18 Shim-pack (150 mm × 4.6 mm, 5 μ) column. The detection was carried out at 280 nm.Results: The retention time of telmisartan and nebivolol HCl was 4.8 min and 6.5 min, respectively. The developed method was validated by evaluating various validation parameters such as linearity, precision, accuracy, robustness, specificity, limit of detection, and limit of quantification according to the international council for harmonization guidelines. The standard calibration curve was obtained in the concentration range of 24–56 μg/ml for telmisartan and 3–7 μg/ml for nebivolol HCl. The overall average % recovery was found out to be 100.35 for telmisartan and 98.84 for nebivolol HCl.Conclusion: Statistical analysis of the data showed that the method is reproducible and selective for the estimation of telmisartan and nebivolol HCl. The proposed method could be used for analysis of telmisartan and nebivolol HCl in their dosage form.

scholarly journals METHOD DEVELOPMENT AND VALIDATION OF LOPINAVIR IN TABLET DOSAGE FORM USING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2018 ◽  
Vol 11 ◽  
Author(s):  
Sunkara Namratha ◽  
Vijayalakshmi A
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Limit Of Quantification ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Objective: Reversed-phase high-performance liquid chromatographic method (RP-HPLC) was developed for the assessment of lopinavir in the dosage form of tablet.Methods: Chromatogram was run through using Kromosil C18 4.5×150 mm using a mobile phase methanol: water of ratio 65:35% v/v with a rate of flow of 0.8 ml/min, measured by UV spectrometric detection at 265 nm. The method developed was validated in terms of precision, accuracy, linearity, and robustness parameters.Results: Retention time of lopinavir established at 2.482 min and percentage R.S.D of lopinavir found to be 1.0% and 0.5%, respectively. The method shows that good linearity range of 30–150 μg correlation coefficient of lopinavir was 0.997. The limit of detection was 2.97 and limit of quantification was 9.92, respectively. The percent purity of lopinavir was 99.87%.Conclusion: The suggested method (Rp-HPLC) for concurrent assay lopinavir was validated, which is appropriate method for the analysis oflopinavir quantitatively in tablet dosage forms and bulk.

scholarly journals Third Derivative Spectrophotometric Method for Simultaneous Determination of Copper and Nickel Using 6-(2-Naphthyl)-2, 3-dihydro-1,2,4- triazine-3-thione

2011 ◽  
Vol 8 (2) ◽  
pp. 587-593 ◽  
Author(s):  
Maliheh Barazandeh Tehrani ◽  
Effat Souri
Keyword(s):  
Simultaneous Determination ◽  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Alloy Sample ◽  
Zero Crossing ◽  
Determination Of Nickel ◽  
Analytical Reagent ◽  
Third Derivative ◽  
Determination Of Copper

A simple and sensitive derivative spectrophotometric method for simultaneous determination of nickel and copper using 6-(2- naphthyl)-2,3-dihydro-1,2,4-triazine-3-thione (NDTT) as a selective analytical reagent was developed. The complexes of metal ions with NDTT were formed immediately in basic media and extracted with chloroform. The zero-crossing measurement technique was found suitable for the direct measurement of the third-derivative value of Ni-NDTT and Cu-NDTT at 501 and 472 nm respectively. Beer’s law is obeyed in the concentration range 1-30 μg/mL for both cations with different ratios. The limit of detection was 0.26 μg/mL and 0.13 μg/mL for copper and nickel respectively. The within day and between day variations showed coefficient of variation (CV%) values less than 2.80 and 2.97 for copper and nickel respectively. The error of the determination method did not exceed 6.50%. Analysis of alloy sample showed that this method can be successfully used for simultaneous determination of Cu and Ni in real samples.

scholarly journals Simultaneous Estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride in Pharmaceutical Tablet Dosage Form by Simultaneous Equation Spectrophotometric Method: A Quality Control Tool for Dissolution Studies

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Deepak Sharma ◽  
Mankaran Singh ◽  
Dinesh Kumar ◽  
Gurmeet Singh
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Simultaneous Equation ◽  
Drug Formulation ◽  
Simultaneous Estimation ◽  
Validation Parameters ◽  
Quality Control Tool ◽  
Cetirizine Hydrochloride ◽  
Ambroxol Hydrochloride ◽  
Tablet Dosage

Ambroxol Hydrochloride and Cetirizine Hydrochloride are used for the treatment of bronchitis, cough, and allergy. A simple, economical, accurate, and precise method for simultaneous estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride in tablet dosage form has been developed. Simultaneous equation method based on measurement of absorbance at two wavelengths, that is, 244 nm and 230 nm, λmax of Ambroxol Hydrochloride and Cetirizine Hydrochloride in pH 6.8 phosphate buffer. Both of these drugs obeyed Beer-Lambert’s law in the concentration range of 2–18 µg/mL for Ambroxol Hydrochloride and 2–20 µg/mL for Cetirizine Hydrochloride. The high values of correlation coefficient (R) indicated good linearity of calibration curve for both the drugs. The accuracy and precision of method were determined and the method was validated statistically. Result of percentage recovery study confirms the accuracy of proposed method. As per the ICH guidelines, the method validation parameters checked were linearity, accuracy, precision, and assay of drug formulation. Based on the results obtained, it can be concluded that the proposed simultaneous equation spectrophotometric method for simultaneous estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride is rapid, economical, accurate, precise, and reproducible. Hence, the proposed method can be employed for quantitative estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride from their tablet dosage form.

scholarly journals Development and ICH Validation of a RP-HPLC-UV Method for the Quantification of Thimerosal in Topic Creams

2017 ◽  
Vol 60 (4) ◽  
Author(s):  
Guadalupe Pérez-Caballero ◽  
Nancy Muro-Hidalgo ◽  
Elvia Adriana Morales-Hipólito ◽  
Alma Villaseñor ◽  
Raquel López-Arellano
Keyword(s):  
Phosphate Buffer ◽  
Limit Of Detection ◽  
Extraction Procedure ◽  
Reversed Phase ◽  
Sample Treatment ◽  
Limit Of Quantification ◽  
Rp Hplc ◽  
Validation Parameters ◽  
Quality Control Tool

A reversed phase high-performance liquid chromatography (RP-HPLC) method for determination of Thimerosal (TMS) in topical creams was optimized and validated according to the ICH guidelines which include accuracy, precision, selectivity, robustness, limit of detection (LOD), limit of quantification (LOQ), linearity and range. For topical creams, sample treatment is often an overwhelming step essentially due to its oily nature. For the first time a simple and robust extraction procedure for TMS using phosphate buffer (pH 5.5, 0.2M) was successfully developed. This method describes the TMS quantitation by HPLC in a topical product containing 0.01% fluocinolone acetonide (FLA) as the active molecule. The HPLC separation was achieved on a Column Symmetry® and a methanol: phosphate buffer (pH 2.5, 0.05M) 70:30 v/v mobile phase and wavelength 218 nm. Results from both standards and samples showed adequate validation parameters. Noteworthy, linearity was within the range 1.2 - 2.8 μg/mL. Additionally, robustness and TMS stability were established after sample extraction. The method provides an efficient and safe quality control tool for determination of TMS in topical creams.

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