scholarly journals UV Method Development and Validation of Ellagic Acid for its Rapid Quantitative Estimation

2019 ◽  
Vol 7 (1) ◽  
pp. 1-5
Author(s):  
Harsheen Kaur ◽  
Arti Thakkar ◽  
Kalpana Nagpal
Keyword(s):  
Ellagic Acid ◽  
Method Development ◽  
Limit Of Detection ◽  
Quantitative Estimation ◽  
Uv Spectroscopy ◽  
Entrapment Efficiency ◽  
Good Recovery ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

Development and validation of a simple UV- Spectroscopy method was done for the quantitative analysis of Ellagic Acid (EA). The stock solution of 50μg/ml was prepared and scanned, for which absorption maxima was found to be 277nm. Further dilutions to different concentrations (1-5μg/ml) were prepared and analyzed at 277nm. The method so developed was validated as per ICH guidelines for: linearity, robustness, precision, accuracy, limit of detection and quantification. The Lambert- Beer’s law is followed in the range (1-5μg/ml) with correlation coefficient value 0.9994. It was observed that the method is precise and accurate for EA analysis with good recovery percent of 94.47% to 106.83%. The method developed was further employed for determining the entrapment efficiency of ellagic acid and its release from its nanoparticle dosage form. The method may be utilized for determining the concentration of EA when present as formulation and in combination with other drugs.

scholarly journals Method Development and Validation of Quantitative Estimation of Vilazodone Hydrochloride by UV and RP-HPLC

2020 ◽  
Vol 13 (4) ◽  
pp. 362-373
Author(s):  
Gayathri Nallathambi ◽  
V Sekar ◽  
Surendra kumar.M
Keyword(s):  
Method Development ◽  
Limit Of Detection ◽  
Quantitative Estimation ◽  
Forced Degradation ◽  
Limit Of Quantification ◽  
Ich Guidelines ◽  
Potassium Hydrogen ◽  
Method Development And Validation ◽  
Development And Validation ◽  
High Degree

The aim of the study is to develop some new analytical method development and Validation of Quantitative Estimation of Anti-depressant Drug Vilazodone by UV and HPLC was found to be simple, specific, precise, accurate, rapid and economical. The method was developed and validated as per ICH guidelines, concerning accuracy, precision, linearity, ruggedness, limit of detection, limit of quantification and robustness and forced degradation studies. The GRACE ODS phenyl column (4.6 x 150mm,5μm) column was maintained at an ambient temperature and 232 nm λ max conditions. The mixture of di-potassium hydrogen phosphate with buffer (pH 7.4) and methanol in proportion 60:40v/v mobile phase was used in the flow rate of 1 ml/min. All validation methods shows good reproducibility and good recovery. The mean recoveries was found in the range between 99.6-99.9%. with % RSD values were within 2. The limit of detection and limit of quantification were found to be 0.05 μg/ml and 0.01 μg/ml respectively. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.

Analytical Method Development and Validation of Glipizide to Determine Residual solvents by head Space-Gas Chromatography

2021 ◽  
pp. 2440-2444
Author(s):  
Sanapala Srinivasa Rao ◽  
A. Vijayalakshmi
Keyword(s):  
Gas Chromatography ◽  
Method Development ◽  
Limit Of Detection ◽  
Dimethyl Formamide ◽  
Analytical Methodology ◽  
Residual Solvents ◽  
Flame Ionization ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

Residual solvents in Pharmaceuticals are termed as organic volatile impurities. These are the chemicals that are used in the manufacture of drug substance or excipients or use in the preparation of final formulation. Most of the available methods use liquid chromatography which could be expensive and time consuming. Hence, an analytical methodology was developed for the quantification of residual solvents in Glipizide using a headspace gas chromatography (HSGC) with the help of flame ionization detector (FID). Methanol, acetone and dimethyl formamide as residual solvents were determined in Glipizide. Analysis was performed by headspace GC/FID method on Auto system- HS40. Nitrogen was used as a carrier gas and the separation of residual solvents was achieved by DB-Wax 0.25mm, 0.3mcm column. The thermostat temperature was 115 °C for 40 minutes for each vial. % RSD for nine injections obtained are in acceptance criteria. The correlation coefficient R2 obtained greater than 0.99. The method parameters were validated includes specificity, limit of detection and quantification, accuracy, linearity, precision, and robustness. According to the International Conference on Harmonization (ICH) guidelines, a new simple, specific, accurate and precise method was developed and validated.

Key Aspects of Analytical Method Development and Validation

2019 ◽  
Vol 31 (1) ◽  
pp. 32-39
Author(s):  
Suman Shrivastava ◽  
Pooja Deshpande ◽  
S. J. Daharwal
Keyword(s):  
Method Validation ◽  
Analytical Method ◽  
Method Development ◽  
Limit Of Detection ◽  
Limit Of Quantification ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Key Aspects ◽  
Development And Validation

Development of a method is crucial for discovery, development, and analysis of medicines in the pharmaceutical formulation. Method validation could also be thought to be one in all the foremost well-known areas in analytical chemistry as is reproduced within the substantial variety of articles submitted and presented in peer review journals every year. Validation of an analytical procedure is to demonstrate that it's appropriate for its intended purpose. Results from method validation are often wont to decide the quality, reliability and consistency of analytical results. Analytical methods need to be validated or revalidated. This review describes general approach towards validation process and validation parameters to be considered during validation of an analytical method. It also refers to various regulatory requirements like WHO, USFDA, EMEA, ICH, ISO/IEC. The parameters described here are according to ICH guidelines which include accuracy, precision, specificity, limit of detection, limit of quantification, linearity range and robustness.

Method Development and Validation of Evening Primrose oil and its Pharmaceutical dosage form by Simple UV- Spectrophotometric Method

2021 ◽  
pp. 133-138
Author(s):  
Shaheen Begum ◽  
Jahnavi. B ◽  
Nameera Jabeen ◽  
Umema Naaz. T ◽  
Sandhya. M
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Quantitative Estimation ◽  
Spectroscopic Method ◽  
Evening Primrose Oil ◽  
Pharmaceutical Dosage Form ◽  
Evening Primrose ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

In the present work, simple and sensitive UV spectroscopic method has been developed for the quantitative estimation of Evening Primrose Oil in efem capsule. Cyclohexane was used as solvent. In the range of 100-500μg/ml, the linearity of Evening Primrose Oil shows a correlation co-efficient of 0.999. The UV detection wavelength was 233nm. The percentage RSD for precision and accuracy of the method was found to be less than 2%(LOQ) of 23μg/ml and (LOD) of 7.5μg/ml. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Evening Primrose Oil and in formulation dosage form.

scholarly journals Analytical method development and validation for simultaneous estimation of monoammonium glycyrrhizinate and sennoside-B in polyherbal laxative tablet using RP-HPLC

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Madhavi Patel ◽  
Shivangi Chauhan ◽  
Vishal Patel ◽  
Hardik Soni ◽  
Vikram Trivedi
Keyword(s):  
Method Development ◽  
Limit Of Detection ◽  
Correlation Coefficients ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Accuracy And Precision ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Determination Of Parameters ◽  
Development And Validation

Abstract Background Standardization of polyherbal medicine though being the need of the hour is a toilsome task. Among the various methods employed for quality control and standardization of polyherbal medicine, phytochemical profiling is of utmost importance as it signifies the quality as well as efficacy of the medicine. The work was aimed to develop and validate a simple, quick, and accurate RP-HPLC technique for simultaneous assessment of monoammonium glycyrrhizinate and sennoside-B in a polyherbal laxative tablet. The phytomarkers were effectively quantified by RP-HPLC system on C18 analytical column using gradient mobile phase consisting of phosphate buffer to acetonitrile with the detector wavelength set at 254 nm. This developed method was validated by determination of parameters like accuracy, linearity, precision, limit of detection, and quantification as well as robustness according to ICH guidelines. Results Calibration curve of both phytomarkers showed excellent linear correlation coefficients. LOD and LOQ were also calculated by equation. Precision studies were carried out using intra-day and inter-day intervals and RSD values were found to be less than 2.00%. The method was found to be accurate, which was evident from 98.96 to 101.39% and 99.17 to 100.67% recovery of monoammonium glycyrrhizinate and sennoside-B, respectively, when the formulation was spiked with the respective phytomarkers. Conclusion The validated method can be employed as standardization tool for herbal formulations with accuracy and precision. The developed method will assist in maintaining the good quality and batch to batch uniformity of polyherbal formulations containing Yashtimadhu, Swarnpatri, and Aragvadha as active ingredients.

scholarly journals Method Development and Validation of Salmeterol xinofoate by HPLC

2021 ◽  
Vol 6 (6) ◽  
pp. 52-63
Author(s):  
Sahebrao H. Shembade ◽  
Sagar S. Landage ◽  
Ashapak M. Tamboli ◽  
Ritesh S. Bhate ◽  
Kaustubh V. Gavali ◽  
...  
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Method Development ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Chromatography Method ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Liquid Chromatography Method ◽  
Development And Validation

A rapid and precise high performance liquid chromatography method has been developed for the validation of Salmeterol xinofoate in its pure dosage form. The separation was carried out on Agilent Zorbax Bonus RP- (250mm ×4.6mm 5μ) column with a mobile phase consisting of 0.1% Formic acid: Acetonitrile in the ratio of 64:36 v/v as a mobile phase and flow rate is 1ml/min. The detection was carried out at wavelength 234nm. The column thermostatically controlled at 30℃. The retention time of Salmeterol was found to be 1.96 min. The Salmeterol xinofoate followed linearity in the concentration range of 40-60μg/mL with r2= 0.999. The developed method was validated for sensitivity, accuracy and precision. The sample was scanned from 200- 400nm with PDA detector. The % recovery of sample was found to be. The LOD and LOQ of the Salmeterol xinofoate was found to be 2.67μg/ml and 8.08μg/ml respectively. The suitability of this HPLC method for quantitative estimation of Salmeterol xinofoate was proved by validation by the requirements of ICH guidelines.

scholarly journals Development and Validation of UV Spectrophotometric Method of Mesalamine Using Hydrotropic Solubilizing Agents

2021 ◽  
Vol 12 (3) ◽  
pp. 2291-2296
Author(s):  
Bhavani N. L. D. ◽  
Gowtham Reddy Cheruku ◽  
Bhargava Sri Harsha Polina ◽  
Dheeraj Kotagiri ◽  
Jnanendra Kumar Korukollu
Keyword(s):  
Method Development ◽  
Limit Of Detection ◽  
Regression Equations ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Technical Requirements ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Method Development And Validation ◽  
Development And Validation

The work was proposed to discuss method development and validation of the drug Mesalamine by using hydrotropic solubilizing agents. An uncomplicated, accurate, and precise method was developed for the drug Mesalamine in bulk as well as Pharmaceutical dosage form. 5M Urea was used as the hydrotropic solubilizing agent to enhance the solubility of the drug. The maximum wavelength (ʎ max) for Mesalamine was found to be 241nm. The validation was performed as per International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines for Accuracy, linearity, precision, Limit of detection (LOD) and Limit of quantification (LOQ). Percentage recovery (%) of Mesalamine was ascertained to be between 95 to 98%. Linearity for Mesalamine was observed between 2-10 µg/ml. Regression equation y=0.0571x-0.0186, regression coefficient (r²) is 0.9996 for Mesalamine. Inter day and intraday precision were checked, % relative standard deviation values were less than 2 for both the methods. Limit of detection (LOD) and Limit of quantification (LOQ) values were derived using regression equations. LOD value was found to be 0.55 µg/ml. LOQ value was found to be 1.67 µg/ml. The assay of the marketed formulation was performed and the results of the assay were obtained by the proposed method. The results are in between 98-102%. So, the method developed was simple and economical that can be adopted for routine tests.

RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF LURASIDONE HYHROCHLORIDE IN BULK AND TABLET FORM

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (01) ◽  
pp. 28-34
Author(s):  
K. Vijaya Sri ◽  
M. Shiva Kumar ◽  
A. Sravani ◽  
Keyword(s):  
Method Development ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Tablet Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation

The RP-HPLC were developed and validated for the estimation of lurasidone HCl as per ICH guidelines. A simple, fast, accurate and precise RP-HPLC method was developed by using methanol: water containing 0.01% ortho phosphoric acid in the ratio of 70:30 (V/V). The method was developed in Eclipse C18 column (100 mm × 4.6 mm, 3.5 μm particle size). The method was found to be linear in the range of 2.5- 15µg/mL with a correlation coefficient value of 0.999. The accuracy studies of RP-HPLC method was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range of 100.1-100.6% .The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.30-0.92. Satisfactory validation was also obtained from recovery (99.8%) studies, intra-day and interday precision and robustness 2%. The proposed method was found to be accurate, precise and rapid for the analysis of lurasidone.

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 RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms

2013 ◽  
Vol 49 (2) ◽  
pp. 359-366 ◽  
Author(s):  
Mustafa Çelebier ◽  
Tuba Reçber ◽  
Engin Koçak ◽  
Sacide Altinöz
Keyword(s):  
Method Development ◽  
Internal Standard ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

Rivaroxaban, an anti-clotting medication, acts at a crucial point in the blood-clotting process and stops the formation of blood clots. In this study, RP-HPLC method was developed for the determination of rivaroxaban in tablets (Xarelto® (10 mg)). Phenomenex Luna 5 µm C18 100 Å LC Column (250 x 4.6 mm) was used at 40 ºC. Isocratic elution was performed with ACN:Water (55:45 v/v) mixture. The flow rate was 1.2 mL min-1 and UV detection was at 249 nm. Internal standard (Caffeine) and rivaroxaban were eluted within 2.21 and 3.37 minutes, respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range 0.005 - 40.0 µg mL-1. The method was accurate, precise, robust and rapid. Thus, it was applied successfully for the quality control assay of rivaroxaban in tablet dosage form.

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