Quantitative Spectrophotometric Estimation of Prednisolone in Tablet Dosage Form Using Eco-friendly Green Solvent and by applying Beer-Lambert’s Law Mathematical Equation Method

2021 ◽  
pp. 155-160
Author(s):  
Sana Tabassum ◽  
Ajitha M
Keyword(s):  
Lupus Erythematosus ◽  
Dosage Form ◽  
Quantitative Estimation ◽  
Low Cost ◽  
Chronic Obstructive ◽  
Green Solvent ◽  
Ich Guidelines ◽  
Label Claim ◽  
Specific Absorbance ◽  
Tablet Dosage

Prednisolone is a widely used synthetic glucocorticoid drug used in the treatment of allergies, inflammatory conditions, auto-immune disorders, acute and chronic obstructive pulmonary disease, rheumatoid arthritis, systemic lupus erythematosus, dermatitis, eye inflammation, asthma and multiple sclerosis. A simple and economical method was developed using eco-friendly green solvent. In this developed method the eco-friendly green solvent used was ethanol which is available easily. The method was projected to quantitative estimation and assay of Prednisolone in Prednisolone dispersible tablet dosage form. The amount and percent label claim of Prednisolone in tablet dosage form was estimated using Beer-Lambert’s law. Specific absorbance (A1%1cm) of Prednisolone is 415 at lambda max of 243 nm. The method developed was validated as per ICH guidelines. The proposed method was found to be simple, accurate, sensitive, precise, linear and rugged. The method obeys Beer-Lambert’s Law in the concentration range of 2.5-20μg/mL, as the r2 value was found to be 1.000. The mean percent recovery was found to be within acceptable range as per ICH guidelines. Hence the developed method can be used in regular quantitative analysis. The developed method acquires only one green solvent, low cost analytical equipment and the percent label claim can be calculated in the assay of Prednisolone tablets without using any standards solution or standard graph by just employing specific absorbance value in Beer-Lambert’s law, thereby concentration of drug can be calculated. As this method is simple, economical and eco-friendly it can be used elegantly and routinely in analytical laboratories and industries for estimation of Prednisolone in tablet formulation.

scholarly journals Analytical Method Development and Validation for Estimation of Silymarin in Tablet Dosage form by HPLC

2020 ◽  
pp. 22-31
Author(s):  
Sneha Singh ◽  
Mohit Saini ◽  
Jitender K. Malik ◽  
Amit Kumar
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Low Cost ◽  
Pharmaceutical Preparations ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

Silymarin is extracted from the Silybum marianum (milk thistle) plant C25 containing flavonoid mixture. It is mainly used for its effect in liver disease. The HPLC of silymarin tablet had been validated for precision, accuracy (recovery), selectivity & Linearity. In the present study, an attempt was made to provide a newer, simple, sensitive, precise and low cost HPLC method for the effective quantitative determination of silymarin as an active pharmaceutical ingredient as well as in pharmaceutical preparations without the interferences of other constituent in the formulations. HPLC method is developed and validated for various parameters as per ICH guidelines. The validated method was effectively useful to the commercially accessible pharmaceutical dosage form, yielding extremely good and reproducible result.

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.

HPLC METHOD DEVELOPMENT FOR ESTIMATION OF RAMELTEON IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (06) ◽  
pp. 20-23
Author(s):  
S Sahoo ◽  
◽  
P. K. Panda ◽  
S. K. Mishra
Keyword(s):  
Flow Rate ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Ich Guidelines ◽  
Hplc Method Development ◽  
Tablet Dosage ◽  
Good Agreement

A simple, fast, accurate and precise reverse phase HPLC method is developed and described for the determination of ramelteon in tablet dosage form. Chromatography was carried on an ODS column using a mixture of acetonitrile and phosphate buffer pH 7.0 (35:65 V/V) as the mobile phase at a flow rate of 1.0 mL/min with detection at 286 nm. The retention time of the drug was 7.7 min. The procedure was validated for linearity, precision, accuracy, and robustness. The developed method was validated for linearity from 50 to 150% which shows the method is quite linear with a correlation coefficient of 0.999, for precision which includes system precision, method precision, intraday and by another analyst on another day, and accuracy. The %RSD for system precision was observed to be 1.1, whereas the method precision was observed to be 0.2. The % recovery from ‘accuracy’ studies yielded the recovery of 99.7-101.5% which indicates the capability of the method, and finally for robustness that includes studies w.r.t. change in flow rate, the percentage of organic modifier and pH. As per ICH guidelines, method validation results are in good agreement. The proposed method was simple, sensitive, precise and accurate.

scholarly journals Development and Validation of RP-HPLC Method for the Estimation of Sitagliptin Phosphate in Tablet Dosage Form

2017 ◽  
Vol 2 (03) ◽  
pp. 41-45
Author(s):  
Sireesha D ◽  
Sai Lakshmi E ◽  
Sravya E ◽  
Vasudha Bakshi
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Room Temperature ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Isocratic Mode

A new simple, rapid, specific, accurate, precise and novel Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the estimation of Sitagliptin Phosphate in the pharmaceutical dosage form. The chromatographic separation for Sitagliptin was achieved with mobile phase containing methanol, Thermoscientific C18 column, (250x4.6 particle size of 5μ) at room temperature and UV detection at 248 nm. The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Sitagliptin was 1.91min. The above method was validated in terms of linearity, accuracy, precision, LOD and LOQ in accordance with ICH guidelines.

REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF REGORAFENIB IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (06) ◽  
pp. 63-68
Author(s):  
R. Raut ◽  
◽  
A. Patil ◽  
V. K Munipalli ◽  
M. Patel ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Control Analysis ◽  
Reverse Phase ◽  
Ich Guidelines ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple precise and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for quantitative determination of Regorafenib in tablet dosage form. In this method Hypersil Gold (C18, 150mm× 4.6mm id, 3μ) column with mobile phase consisting of Trifluoroacetic acid (0.2% v/v) and Acetonitrile in the ratio of (50: 50 v/v) at 400C in an isocratic mode was used. The detection was carried out at 260 nm and 20μL injection volume was selected with the flow rate 1mL/min. The linearity range of Regorafenib shows concentration between 5-200 μg/mL. The regression coefficient obtained was 0.999. Retention time of Regorafenib was found to be 6.49 minutes. Acetonitrile and Water in the ratio of (3:1) was used as a diluent. The method was validated as per ICH guidelines and is simple, fast, accurate, precise and can be applied for routine quality control analysis of Regorafenib in tablet dosage form.

scholarly journals UV SPECTROPHOTOMETRIC ANALYSIS AND VALIDATION OF ACYCLOVIR IN SOLID DOSAGE FORM

2020 ◽  
pp. 100-103
Author(s):  
AKSHATA LASURE ◽  
AFAQUE ANSARI ◽  
MALLINATH KALSHETTI
Keyword(s):  
Dosage Form ◽  
Quantitative Estimation ◽  
Spectroscopic Method ◽  
Pharmaceutical Formulations ◽  
Spectrophotometric Analysis ◽  
Pharmaceutical Dosage Form ◽  
Solid Dosage ◽  
Ich Guidelines ◽  
Double Beam ◽  
Routine Assay

Objective: A new, economical, sensitive, simple, rapid UV spectrophotometric method has been developed for the estimation of Acyclovir in pure form and pharmaceutical formulation. Methods: This UV method was developed using distilled water as a solvent. In the present method, the wavelength selected for analysis was 254 nm. UV-Visible double beam spectrophotometer (Systronic 2201) was used to carry out the spectral analysis. The ICH guidelines were used to validate the method. Results: The method was validated for linearity, range, accuracy, precision, robustness, LOD and LOQ. Linearity was found in the range of 5-30µg/ml. Accuracy was performed by using a recovery study. The amount of drug recovered was found to be in the range of 100.1-100.5 %. The % RSD value was found to be less than 2. Conclusion: The proposed UV spectroscopic method was found to be accurate, precise, stable, linear, specific, and simple for quantitative estimation of acyclovir in bulk and pharmaceutical dosage form. Hence the present UV spectroscopic method is suitable for the routine assay of acyclovir in bulk and pharmaceutical formulations.

scholarly journals A NEW VALIDATED THIRD ORDER DERIVATIVE SPECTROSCOPIC METHOD FOR SIMULTANEOUS ESTIMATION OF METOPROLOL SUCCINATE AND RAMIPRIL IN TABLET DOSAGE FORM

2020 ◽  
pp. 54-59
Author(s):  
ALEKHYA B. ◽  
M. SINDHUSHA ◽  
SORAJ K. RAUL ◽  
GOPAL K. PADHY
Keyword(s):  
Quantitative Analysis ◽  
Dosage Form ◽  
Spectroscopic Method ◽  
Simultaneous Estimation ◽  
Third Order ◽  
Metoprolol Succinate ◽  
Zero Crossing ◽  
Ich Guidelines ◽  
Tablet Dosage

Objective: The objective of the present work is to develop and validate a new UV derivative spectrophotometric method for simultaneous estimation of metoprolol succinate and ramipril in methanol: water (50:50v/v). Methods: “Zero crossing technique” was chosen for quantitative determination. The zero-crossing points (ZCP’s) were found to be 209 nm where metoprolol succinate was quantified and 211 nm where ramipril was quantified. This method was then subjected to accuracy, linearity, sensitivity and reproducibility according to ICH guidelines to ensure and confirm its validity. Results: The method was found to be obeying Beer’s law in the range of 10-50 µg/ml and 5-25 µg/ml for metoprolol succinate and ramipril, respectively. The % recoveries were observed between the range of 99.2-100.2 for metoprolol succinate and 99.57-99.86 for ramipril. The intra-day and inter-day results showed reproducibility. Conclusion: It can be concluded that the developed third-order UV derivative spectroscopic method for the simultaneous determination of metoprolol succinate and ramiprilcan be recommended for routine quantitative analysis.

Development and validation of RP-HPLC/UV methods for the estimation of Risedronate sodium in pure and pharmaceutical dosage form

2019 ◽  
Vol 6 (1) ◽  
Author(s):  
Ananda Thangadurai Subramaniam ◽  
Devi Velmurugan ◽  
Sambathkumar Ramanathan ◽  
Kamalakannan Dhanabalan ◽  
Jambulingam Munusamy ◽  
...  
Keyword(s):  
Dosage Form ◽  
Uv Spectroscopy ◽  
Hplc Method ◽  
Dilution Method ◽  
Control Analysis ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

Recent study was conducted to develop and validate analytical methods for estimation of Risedronate sodium in pure and pharmaceutical dosage form using UV Spectroscopy and               RP- HPLC method. The first method (Method A) based on the UV Spectroscopy using 0.1M Hcl as diluent lambda max was found at 261 nm. Linearity existed perceived in the concentration between 10-50 μg/ml (r 2 = 0.999) for the method. The method was validated pertaining to linearity, precision and accuracy studies, LOD and LOQ consistent with ICH guidelines. The second method (Method B), based on determination of Risedronate sodium tablet dosage form by RP-HPLC method.  Chromatography separation was carried out on a C18 (150X4.6 mm x5 µ) SS Column using Methanol: Ammonium formate (85:15) as the mobile phase at a flow rate of   1.0 ml/min. The chromatographic analysis was carried out in the reflectance and absorbance mode at 254 nm and retention time of the drug was found to be 1.11 ml/min for standard and tablet. Linear responses of the drug were in the concentration range of 200-1000 µg/ml. The accuracy of the method was assessed by standard dilution method and found to be 98% to              102% .The results of the analysis were validated statistically prism software. The method established was found to be simple, precise, linear, accurate and sensitive. The developed method can be used for routine quality control analysis of Risedronate sodium in pure and pharmaceutical dosage form.

scholarly journals Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC

2020 ◽  
Vol 10 (4) ◽  
pp. 97-101
Author(s):  
Mithun Rudrapal ◽  
Nazim Hussain
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Reversed Phase ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Average Percentage ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of gemifloxacin in the tablet dosage form. The separation was achieved on a reversed-phase C-18 column (250 x 4.6 mm i.d., 5 µm) using a mobile phase consisting of acetonitrile/acetate buffer of pH 4.5 (70:30 v/v) at a flow rate of 1.0 ml/min and a detection wavelength of 244 nm. The separation was carried out on an isocratic mode at room temperature. The method was validated as per ICH guidelines for linearity, accuracy, precision, robustness, LOD, LOQ and specificity. The developed method showed good linearity over the concentration range of 50-150 µg/ml (r2=0.995). The average percentage recovery was 99.77%. The LOD and LOQ were 12.678 µg/ml and 14.261 µg/ml, respectively. Based upon validation studies, the developed method can be successfully applied for the routine analysis of gemifloxacin in bulk drugs as well as pharmaceutical dosage forms. Keywords: Gemifloxacin, Tablet dosage form, RP-HPLC, Validation, ICH guidelines

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