scholarly journals Analytical method development and its validation for simultaneous estimation of catechin and curcumin by HPTLC from ancho lean tablets

2018 ◽  
Vol 6 (02) ◽  
pp. 23-30
Author(s):  
Shraddha Joshi ◽  
Varsha M. Jadhav ◽  
Vilasrao J. Kadam
Keyword(s):  
Method Development ◽  
Regression Coefficient ◽  
Limit Of Detection ◽  
Analysis Data ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Ich Guidelines ◽  
Precision Limit ◽  
Rf Values ◽  
Hptlc Method

HPTLC method which is simple, particular and robust has been developed for the simultaneous estimation of Catechin and Curcumin from an Ayurvedic formulation. The method was validated using parameters such as linearity, specificity, and precision, limit of quantification (LOQ), limit of detection (LOD), accuracy and robustness as per ICH guidelines. The present work deals with development of HPTLC method for simultaneous estimation of catechin and curcumin in marketed Ayurvedic formulations. Chromatographic separation of the drugs was performed on Merck TLC aluminium plates pre-coated with silica gel 60F254 as the stationary phase. The mobile phase selected was toluene:ethyl acetate: formic acid (7: 2.5: 0.5 v/v/v). The sample solutions were prepared in methanol and linear ascending development was carried out in twin trough glass chamber and scanned at 269 nm using Camag TLC scanner. The two markers were resolved successfully with Rf values 0.23±0.02 and 0.58±0.02 for catechin and curcumin, respectively. The regression analysis data indicated good linear relationship for the calibration plots for Catechin and Curcumin in the range of 1900-2500 ng/spot and 200-800 ng/spot and regression coefficient was 0.990 and 0.997 respectively. The proposed method can be used for the estimation of these markers in combined Ayurvedic formulation.

scholarly journals UPLC Method Development and Validation for the Determination of Chlophedianol Hydrochloride in Syrup Dosage Form

2017 ◽  
Vol 2 (02) ◽  
pp. 25-31
Author(s):  
Anas Rasheed ◽  
Osman Ahmed
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Linear Regression Analysis ◽  
Analysis Data ◽  
Calibration Plot ◽  
Limit Of Quantification ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation

A specific, precise, accurate ultra pressure liquid chromatography (UPLC) method is developed for estimation of chlophedianol hydrochloride in bulk drug and syrup dosage form. The method employed with Hypersil BDS C18 (100 mm x 2.1 mm, 1.7 μm) in a gradient mode, with mobile phase of methanol and acetonitrile in the ratio of 65:35 %v/v. The flow rate was 0.1 ml/min and effluent was monitored at 254 nm. Retention time was found to be 1.130±0.005 min. The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ)in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 20-100 μg/ml respectively. The LOD and LOQ values were found to be 2.094(μg/ml)and 6.3466(μg/ml)respectively. No chromatographic interference from syrup excipients and degradants were found. The proposed method was successfully used for estimation of chlophedianol hydrochloride in syrup dosage form.

HPTLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CHLORTHALIDONE AND IRBESARTAN IN COMBINED TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (07) ◽  
pp. 46-52
Author(s):  
P Kalaiselvi ◽  
◽  
K. G. Lalitha
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Ammonia Solution ◽  
Dosage Forms ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Forms ◽  
Tablet Dosage ◽  
Hptlc Method

A simple, accurate and rapid high performance thin layer chromatography (HPTLC)-densitometry method was developed for separation and determination of chlorthalidone (CHL) and irbesartan (IBS) in pharmaceutical dosage forms. The compounds were separated on silica gel 60 GF254, HPTLC plates using mobile phase of toluene: ethyl acetate: acetonitrile: methanol: ammonia solution (25%) [5:2:2:1:0.2 v/v/v/v] as compact spots at Rf of 0.57 for chlorthalidone and Rf of 0.36 for irbesartan. Densitometric detection was performed at 254 nm. The method was validated in terms of linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). The calibration curves were linear in the range of 12.5-75 ng/spot for CHL and 150-900ng/spot for IBS. For CHL recovery varied in range of 99.26-101.25% and for IBS recovery varied in range of 99.76-100.40%. The LOD was found 1.33 and 11.34 ng/spot for CHL and IBS respectively. The LOQ was found 4.03 and 14.37 ng /spot for CHL and IBS respectively. It was observed that the proposed HPTLC method could be used for efficient analysis of the CHL and IBS in combined tablet dosage forms.

scholarly journals Simultaneous estimation of salbutamol sulphate and ambroxol HCl from their combined dosage form by UV-VIS spectroscopy using simultaneous equation method

2020 ◽  
Vol 13 (3) ◽  
pp. 127-134
Author(s):  
Wrushali A. Panchale ◽  
Chaitanya A. Gulhane ◽  
Jagdish V. Manwar ◽  
R. L. Bakal
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Simultaneous Equation ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Salbutamol Sulphate ◽  
Ich Guidelines ◽  
Vis Spectroscopy ◽  
Precision Limit

A simple UV-Vis Spectrophometric method was developed for the simultaneous determination of salbutamol sulphate and ambroxol HCl (AMB) from their combined dosage form. The method employs formation and solving of simultaneous equation using 242 nm and 272 nm as two analytical wavelengths (λMax of the drugs) of detection. Both the drugs obeyed Beer-Lambert’s law over the concentration range 1-50 μg/mL for salbutamol sulphate and 10-50 μg/mL for ambroxol HCl, respectively. The developed method was validated for Accuracy, Precision, Limit of Detection and Limit of Quantification as per ICH guidelines and results of analysis were validated statistically.

METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF PIOGLITAZONE AND GLIMEPIRIDE - A UV SPECTROPHOTOMETRIC APPROACH

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (11) ◽  
pp. 30-35
Author(s):  
P. K Kottu ◽  
◽  
A.P. Gadad ◽  
P. M Dandagi
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Estimation Method ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Ich Guidelines ◽  
R Value ◽  
Development And Validation ◽  
Tablet Dosage

Objective: The objective of the present work was to design a simple, accurate, economical and reproducible UV spectrophotometric method for the simultaneous estimation of a two-component drug mixture of pioglitazone and glimepiride in the combined tablet dosage form. Methodology: Simultaneous estimation method that involves maximum absorbance (λ max) of Pioglitazone and Glimepiride at 279.0 nm and 238.0 nm, respectively was developed. The proposed method was validated as per ICH guidelines for accuracy, precision, linearity, limit of quantification (LOQ) and limit of detection (LOD). The calibration curves were linear in the concentration range for pioglitazone (r value) and for glimepiride (r value) and were found to obey Beers law in the linear concentration ranges. Statistical analysis and drug recovery data showed that simultaneous estimation method was simple, rapid, economical, sensitive,precise and reproducible. Hence, the proposed method was recommended for routine analysis of pioglitazone and glimepiride in combined tablet dosage form.

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF ELLAGIC ACID AND BERBERINE IN POLYHERBAL FORMULATION BY RP-HPLC

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (05) ◽  
pp. 52-57
Author(s):  
Pratiksha More ◽  
◽  
Aruna P. Jadhav
Keyword(s):  
Ellagic Acid ◽  
Limit Of Detection ◽  
Low Cost ◽  
Analysis Data ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Polyherbal Formulation ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Development And Validation

An easy, selective, rapid, specific and low cost reverse phase HPLC technique has been developed for the simultaneous estimation of ellagic acid and berberine from a polyherbal formulation. The method was carried out on a Hemochrom Intsil [C18 (250 X 4.6 mm, 5 µ)] column with the mobile phase consisting of methanol: 0.1 % orthophosphoric acid (80:20V/V) at a flow rate of 0.8 mL/min. Detection was carried out at 234 nm. The retention times of ellagic acid and berberine were 4.00 and 2.97 min, respectively. The regression analysis data indicated a good linear relationship for the calibration plots for ellagic acid and berberine in the range of 2-8 µg/mL and 20-80 µg/mL and the regression coefficient was 0.997 and 0.9966, respectively. The accuracy and reliability of the developed method were established by means of comparing numerous validation parameters like linearity, precision, accuracy, robustness, specificity, the limit of quantification and limit of detection, in keeping with the ICH guidelines. The proposed method can be used for the estimation of these markers in other polyherbal formulations.

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.

Development and Validation of the Analytical method for the estimation of a combination of 5-fluorouracil and Imiquimod by RP-HPLC

2021 ◽  
pp. 3313-3318
Author(s):  
Bhupender Tomar ◽  
Ankita Sharma ◽  
Inder Kumar ◽  
Sandeep Jain ◽  
Pallavi Ahirrao
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Pharmaceutical Ingredients ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Liquid Chromatographic

A simple, precise, and accurate reverse phase high performance liquid chromatographic method (RP-HPLC) was developed and validated for the estimation of the combination of 5- Fluorouracil (5-FU) and Imiquimod in active pharmaceutical ingredients (APIs). The method was carried out on Phenomenex C18 (250 × 4.6mm I.D., 5𝜇m) using isocratic elution mode. The mobile phase was used as Acetonitrile: 10mM potassium dihydrogen orthophosphate: triethylamine (40:59.9:0.1, v/v, pH 4.5 with orthophosphoric acid) and Water: ACN (50:50 v/v) was used as a diluent. The concentration of solvents was 1-20µg/ml and the volume of injection was 20µl with the flow rate of 1.2ml/min. The retention times for 5-FU and Imiquimod were found to be 1.9±0.5 and 6.6±0.5 min respectively. The absorption maxima of 5FU and Imiquimod were found 267nm and 227nm respectively. The method was validated as per ICH guidelines. All the data were found within the specified limits. The limit of detection (LOD) and limit of quantification (LOQ) of 5- Fluorouracil were found to be 0.015μg/mL and 0.048 μg/mL, respectively, and Imiquimod was found to be 0.078μg/mL and 0.237μg/mL, respectively. The method developed in the present study was found to be sensitive, specific, and precise and can be applied for the simultaneous estimation of 5-FU and Imiquimod.

METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF THYMOL AND EUGENOL BY USING RP-HPLC IN PURE AND IN EMULGEL FORMULATION

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (07) ◽  
pp. 59-65
Author(s):  
Vinita C. Patole ◽  
Shilpa P. Chaudhari ◽  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Relative Standard ◽  
Peak Areas ◽  
80 A 20 ◽  
Development And Validation

An attempt was made to develop a simple, selective, rapid and precise high-performance liquid chromatography (HPLC) method for simultaneous estimation of thymol and eugenol. Analysis was performed on a C18 column with the mobile phase consisting of solvent %A (water) and solvent %B (acetonitrile) with the following gradient: 0–1 min, 80 % A, 20 % B; 1–7 min, 40 % A and 60 % B; 7–12 min, 10 % A and 90 % B; and 12–15min, 80 % A and 20 % B at a flow rate of 0.6 mL/min. The compounds were well separated on a Thermo Scientific Hypersil BDS RP C18 column (4.6 mm × 150 mm, dp = 5 µm) and ultraviolet detection at 280 nm. The retention times of eugenol and thymol were 10.5 min and 11.6 min, respectively. Validation of the proposed method was carried out according to the guidelines of the International Council on Harmonization (ICH). The linearity of the method is good for thymol and eugenol over the concentration range of 1–50 ppm, and the r 2 values were 0.9996 for both thymol and eugenol. The calculated limit of detection (LOD) value was 0.5ppm and the limit of quantification (LOQ) value was 1ppm for both the analytes. The intra and interday relative standard deviation (RSD) of the retention time and peak areas was less than 3 %.The established method was appropriate, and the two markers were well resolved, enabling efficient quantitative analysis of thymol and eugenol.

scholarly journals Simultaneous Estimation and Validation of Atorvastatin Calcium and Aspirin in Combined Capsule Dosage Form by RP HPLC Method

2012 ◽  
Vol 9 (3) ◽  
pp. 1449-1456
Author(s):  
B. V. Suma ◽  
K. Kannan ◽  
V. Madhavan ◽  
Chandini R. Nayar
Keyword(s):  
Limit Of Detection ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Limit Of Quantification ◽  
Chromatography Method ◽  
Atorvastatin Calcium ◽  
Ich Guidelines ◽  
Phase Liquid ◽  
Liquid Chromatography Method

A new simple, specific, precise and accurate revere phase liquid chromatography method has been developed for estimation of atorvastatin calcium (AST) and ASPIRIN (ASP) simultaneously in a combined capsule dosage forms. The chromatographic separation was achieved on a 5 – micron C 18 column (250x 4.6mm) using a mobile phase consisting of a mixture of Acetonitrile: Ammonium Acetate buffer 0.02M (68:32) pH 4.5. The flow rate was maintained at 0.8 ml/min. The detection of the constituents was done using UV detector at 245 nm for AST and ASP. The retention time of AST and ASP were found be 4.5915 ± 0.0031 min and 3.282 ±0.0024 min respectively. The developed method was validated for accuracy, linearity, precision, limit of detection (LOD) and limit of quantification (LOQ) and robustness as per the ICH guidelines.

scholarly journals A Stability Indicating Assay Method Development and Validation for the Frovatriptan Succinate Monohydrate by Using UV: A Spectrophotometric Technique

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Hitesh Verma ◽  
Surajpal Verma ◽  
Harmanpreet Singh
Keyword(s):  
Method Development ◽  
Limit Of Detection ◽  
Assay Method ◽  
Forced Degradation ◽  
Solution Stability ◽  
Limit Of Quantification ◽  
Experimental Conditions ◽  
Stability Indicating ◽  
Ich Guidelines ◽  
Relative Standard

A new simple, reliable, inexpensive, and accurate method was developed for the quantification of Frovatriptan Succinate Monohydrate in different physiological media at 244 nm in bulk and in tablet dosage forms. The developed method is an attempt to surpass the disadvantages associated with the reported methods, namely, less sensitive and tedious in usage for routine purposes. Beer’s law was followed over the range of 1.0 µg/mL to 4.5 µg/mL. Stability indicating assay method was developed and validated as per the ICH guidelines using various parameters, for example, accuracy, precision, limit of quantification, limit of detection, robustness, ruggedness, solution stability, recovery, forced degradation (hydrolysis, photo degradation, thermal degradation, and oxidation), and so forth. Percent relative standard deviation associated with all the parameters was less than 2, showing compliance with the acceptance criteria of ICH guidelines. The developed method was very sensitive as limit of quantification and limit of detection were found to be 0.025 µg/mL and 0.00625 µg/mL, respectively. Forced degradation studies of drug reveal good stability under the chosen experimental conditions.

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