scholarly journals Uniformity Test Tablets Of Atorvastatin on the Market Using Ultraviolet Spectrophotometer

2017 ◽  
Vol 2 (01) ◽  
pp. 18
Author(s):  
Sholichah Rohmani ◽  
Adi Yugatama ◽  
Ahmad Ainurofiq ◽  
Fea Prihapsara ◽  
Felicitas Lady
Keyword(s):  
Limit Of Detection ◽  
Content Uniformity ◽  
Drug Patent ◽  
Trade Name ◽  
First Choice ◽  
Limit Of Quantitation ◽  
Uniformity Test ◽  
Trade Names ◽  
Tablet Dosage

<pre>Atorvastatin is one of the first choice in the treatment of dyslipidemia associated with a decreased risk of cardiovascular disease. Drug patent expires in 2011. Currently in Indonesia circulated atorvastatin dosage tablet innovator , several trade names , and one generic. The purpose of this study was conducted to determine the quality of the preparation of atorvastatin market in Indonesia through tablet dosage uniformity test , so that the appropriate levels of drugs can provide the desired therapeutic effect.</pre><pre>Uniformity tablet dosage form of atorvastatin is done by measuring the uniformity of tablet weight, and content uniformity was done using ultraviolet spectrophotometry in methanol at the maximum wavelength of 246.2 nm and their validity was tested on the value of LOD (limit of detection), and LOQ (limit of quantitation). One- Way ANOVA analyzis was their also conducted.  </pre>The results showed that of the calculation data obtained , either in column A or column B that there is no deviation from the weight of the tablet , and based on the calculation of CV showed that all the tablets of atorvastatin in the market already qualified uniformity of weight as indicated by the value of CV &lt; 5 %, and the levels atorvastatin tablet generic and tablets under the trade name meets the standard requirements of a tablet that in the range 90.0 % - 110.0 % of the amount listed on the label

scholarly journals Application of Fourier Transform Infrared Spectrophotometry Method for Analysis of Metformin Hydrochloride in Marketed Tablet Dosage Form

2021 ◽  
Vol 7 (2) ◽  
pp. 168-177
Author(s):  
Nerdy Nerdy ◽  
Linda Margata ◽  
Dian Ika Perbina Meliala ◽  
Bunga Mari Sembiring ◽  
Selamat Ginting ◽  
...  
Keyword(s):  
Fourier Transform ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Fourier Transform Infrared ◽  
Metformin Hydrochloride ◽  
Infrared Spectrophotometry ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
The Fourier Transform ◽  
Tablet Dosage

The first line drug given for monotherapy for diabetes mellitus type 2 is metformin hydrochloride, which is a biguanide antihyperglycemic drug. The aim of this research was to develop, validate, and apply the Fourier Transform Infrared spectrophotometry method to identify and determine metformin hydrochloride in marketed tablet dosage form. This research included preparation of standard, analysis of samples, and validation of method. The specific wavenumber obtained for qualitative analysis was 1645.68 cm–1 and 1574.8 cm–1. The specific area obtained for quantitative analysis with a single baseline ranged from 1701.53 cm–1 to 1535.66 cm–1. All metformin hydrochloride marketed tablet dosage forms were analyzed and met all of the qualitative and quantitative requirements. The methods met the requirements of method validation for accuracy with a percentage of recovery of 100.22 %, precision with relative standard deviation of 0.48 %, linearity with a correlation coefficient of 0.9992, limit of detection of 11.17 mg per mL, limit of quantitation of 33.84 mg per mL, and good specificity results. In this study, the Fourier Transform Infrared spectrophotometry method was successfully developed and validated for application in identification and determination of metformin hydrochloride in marketed tablet dosage form.

scholarly journals Ultra violet spectrophotometric analysis of Paracetamol, Diclofenac and Tramadol drugs in mixture

2019 ◽  
Vol 24 (3) ◽  
pp. 52
Author(s):  
Eesa M. Thalij1 ◽  
Sarhan A. Salman2 ◽  
, Hasan. M. Hasan1
Keyword(s):  
Limit Of Detection ◽  
Ultra Violet ◽  
Standard Addition ◽  
Spectrophotometric Analysis ◽  
Standard Curve ◽  
Limit Of Quantitation ◽  
Naoh Solution ◽  
Curve Method ◽  
Standard Curve Method ◽  
Tablet Dosage

The aim of this research was  develop and validate an analytical method by Uv spectrophotometric technique for quantitative determination of paracetamol (PAR), diclofenac or voltarine (DIC) and tramadol or tramal (TRA) in tablet dosage form, paracetamol analysis is based on the absorbance maxima were found to be at 243 nm when dissolved in 0.1N H2SO4 as a sample and in 0.1N NaOH solution as a blank,. Quantitative of PAR in sample is achieved by standard addition methods and three ways calculations were used to estimate the amount in the tablet, the expected content per tablet were equal to  (365.60, 361.984, 358.415 mg) and the results were acceptable when compared with original quantity in tablet(350 mg). The method was compared with standard curved method, showed that it is obeyed Beer – lambert law in the concentration range of 0.1–1 µg/ml for standard addition and standard curve methods, with a correlation coefficient of 0.9980 and o.9944. The limit of detection (LOD) for PAR was 0.036 µg/ml while limit of quantitation (LOQ) 0.119 µg/ml, the recovery of three procedure A, B, C of standard addition and standard curve were (104.40, 103.42, 102.40  and 92.995 %) for PAR ,it was found that the results obtained from the standard addition method were better than the result obtained from the standard curve method. The amount of (DIC) and (TRA) drug in tablet sample calculated depending on the  absorbance (A) at 273 nm to give the value 47.44 mg and 47.6 mg per tablet are acceptable when compared with the value of the original quantity in tablet (50mg) and the recovery of the method was found to be (95.2 and 96.0 % ) respectively, the principle of  the method based on the  (A) of mixture at this λ is a total A of the two drugs, which owns different intensity at this λ at different percentages and that apply to the sample and standard for this drugs. Finally this can applied successfully for routine analysis.    http://dx.doi.org/10.25130/tjps.24.2019.047

Validated RP-HPLC Method for the Estimation of Amiloride and Hydrochlorothiazide in Combined Tablet Dosage Form

2021 ◽  
pp. 316-320
Author(s):  
R. Anantha Kumar ◽  
G. Raveendra Babu ◽  
Sowjanya M. ◽  
Ramayyappa M.
Keyword(s):  
Limit Of Detection ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Liquid Chromatographic Method ◽  
Limit Of Quantitation ◽  
Degree Of Exactness ◽  
Phase Liquid ◽  
High Degree ◽  
Tablet Dosage ◽  
Liquid Chromatographic

The aim of this work is to build up a rapid, exact, precise and accurate reverse phase liquid chromatographic method for the simultaneous analysis of amiloride and hydrochlorothiazide in tablet dose structure. The chromatographic strategy was normalized utilizing Hypersil ODS coulmn (250×4.6mm, 5μm molecule size) with UV detection at 210nm and flow rate of 1ml/min. The mobile phase includes phosphate buffer (pH acclimated to 2.5 with dilute Ortho Phosphoric acid) and acetonitrile in the proportion of 60:40 v/v. The linearity of proposed technique was found in the range of 5-30μg/ml (R²=0.999) for amiloride and 50-300μg/ml (R²=0.999) for Hydrochlorothiazide appropriately. The limit of detection (LOD) was discovered to be 0.10μg/ml and 0.40μg/ml for Amiloride and Hydrochlorothiazide appropriately. The limit of quantitation (LOQ) was discovered to be 0.30μg/ml and 1.20μg/ml for Amiloride and Hydrochlorothiazide separately. The retention times of Amiloride and Hydrochlorothiazide were found to be 3.258min and 2.383min separately. The technique was truly recommended and %RSD was found to be under 2 demonstrating high degree of exactness and accuracy. Subsequently proposed strategy can be effectively evaluated for the simultaneous estimation of Amiloride and Hydrochlorothiazide in promoted formulations.

Validated RP-HPLC method for the estimation of Amiloride and hydrochlorothiazide in combined tablet dosage form

2021 ◽  
pp. 207-211
Author(s):  
R. Anantha Kumar ◽  
G. Raveendr Babu ◽  
Sowjanya M. ◽  
Ramayyappa M.
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Limit Of Quantitation ◽  
Phase Liquid ◽  
Tablet Dosage ◽  
Liquid Chromatographic

The aim of this work is to build up a fast, exact, precise and touchy reverse phase liquid chromatographic method for the synchronous assessment of amiloride and hydrochlorothiazide in tablet dose structure. The chromatographic strategy was normalized utilizing Hypersil ODS segment (250×4.6mm, 5μm molecule size) with UV discovery at 210nm and stream pace of 1ml/min. The portable stage includes phosphate buffer (pH acclimated to 2.5 with dilute Ortho Phosphoric acid) and acetonitrile in the proportion of 60:40 v/v. The linearity of proposed technique was examined in the scope of 5-30μg/ml (R²=0.999) for amiloride and 50-300μg/ml (R²=0.999) for Hydrochlorothiazide appropriately. The limit of detection (LOD) was discovered to be 0.10μg/ml and 0.40μg/ml for Amiloride and Hydrochlorothiazide appropriately. The limit of quantitation (LOQ) was discovered to be 0.30μg/ml and 1.20μg/ml for Amiloride and Hydrochlorothiazide separately. The retention times of Amiloride and Hydrochlorothiazide were found to be 3.258min and 2.383min separately. The technique was truly recommended and %RSD was found to be under 2 demonstrating serious level of exactness and accuracy. Subsequently proposed strategy can be effectively evaluated for the synchronous assessment of Amiloride and Hydrochlorothiazide in promoted formulations.

Analytical Method Development and Validation for Simultaneous Estimation of Trimetazidine Hydrochloride and Metoprolol Succinate Using HPTLC

2019 ◽  
Vol 15 (3) ◽  
pp. 243-250 ◽  
Author(s):  
Surendra Agrawal ◽  
Pravina Gurjar ◽  
Bhavik Katheriya
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Simultaneous Estimation ◽  
Metoprolol Succinate ◽  
Limit Of Quantitation ◽  
Label Claim ◽  
Tablet Dosage ◽  
Hptlc Method

Introduction: Trimetazidine and Metoprolol combination is more effective in the treatment of cardiac disorders as compared to single drug therapy.Background: Materials and Methods: A rapid, simple, and sensitive HPTLC method was developed for the simultaneous determination of Trimetazidine and metoprolol from its tablet dosage form and validated. In HPTLC method, standard and sample solutions of Trimetazidine hydrochloride and metoprolol succinate were applied on pre-coated silica gel G 60 F254 TLC plate, and developed by using mobile phase, n-butanol :water: methanol: ammonia as solvent (8.5:0.1:0.1: 0.85, v/v). The drugs on plate were scanned at 213 nm. The method produced compact and well-resolved bands at Rf of 0.32 ± 0.02 and 0.66 ± 0.02 for Trimetazidine Hydrochloride and Metoprolol succinate respectively. The range for linearity was observed as 500-2500 ng band-1 for Trimetazidine hydrochloride and 500-2500 ng band-1 for metoprolol succinate and correlation coefficient were 0.9991 and 0.9997 respectively. Conclusion: The developed method was validated according to the ICH guidelines for precision, accuracy, Limit of detection, Limit of quantitation, specificity and robustness. The method was checked for suitability in determination of Trimetazidine hydrochloride and Metoprolol succinate in their tablet dosage form. The assay result was found to be 99.64 % ± 0.45 and 99.94 % ± 0.53 of percentage label claim for Trimetazidine hydrochloride and Metoprolol succinate respectively.

RP - HPLC METHOD FOR DETERMINATION OF MEBEVERINE HYDROCHLORIDE IN DOSAGE FORMS EMPLOYING MS COMPATIBLE BUFF ERS

INDIAN DRUGS ◽  
2020 ◽  
Vol 57 (03) ◽  
pp. 69-72
Author(s):  
Vijaya Lakshmi Marella ◽  
M. Pavani ◽  
Garikapati Devala Raoa
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Life Time ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Validation Parameters ◽  
Limit Of Quantitation ◽  
Quality Control Tool ◽  
Mebeverine Hydrochloride ◽  
Tablet Dosage

A simple, precise, rapid, accurate and economic reverse phase high performance liquid chromatographic method has been developed for the estimation of mebeverine hydrochloride in bulk and tablet dosage form. The separation was achieved by using kinetex column C18 (150×4.6mm, 5µ) and 15mM ammonium acetate and methanol in proportion of 30:70 v/v as mobile phase, at a flow rate of 1.0mL/min. The detection was carried out at 230nm. The retention time of mebeverine was found to be 3.346 minutes.The limit of detection and limit of quantitation were found to be 0.005µg/mL and 0.016µg/mL, respectively. The reliability of the proposed method was ascertained by evaluating various validation parameters like linearity, precision, accuracy and specificity according to ICH guidelines. The proposed method applies LC-MS compatible buffers which increases the life time of column and can be used as lc-ms compatible method. This method acts as a quality control tool for routine analysis of mebeverine hydrochloride in bulk and tablet dosage forms.

Formulation, method development and validation of water soluble vitamins B1, B2 & B6 in bulk and tablet dosage form by HPTLC method

2018 ◽  
Vol 5 (1) ◽  
pp. 1-4
Author(s):  
Devi Velmurugan ◽  
Jambulingam Munusamy ◽  
Ananda Thangadurai Subramaniam ◽  
Anandkumar Karunakaran ◽  
Abdul Latiff MKM ◽  
...  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Water Soluble ◽  
Good Resolution ◽  
Limit Of Quantitation ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Hptlc Method

In the present study we are reporting  dissolution, method development and validation of water soluble vitamins B1, B2 & B6 in bulk and tablet dosage form by HPTLC method. The method is based on separation of the three vitamins using HPTLC. Thin layer chromatographic plates coated with silica gel 60F254 as the stationary phase and acetonitrile:water (6:4 v/v) as mobile phase. The chromatographic analysis was carried out in the reflectance and absorbance mode at 280 nm. The method was validated with respect to linearity, accuracy and precision, limit of detection and limit of quantitation. It was then applied for analysis of vitamins B1, B2 & B6 in combined tablet dosage form. The above method developed was reproducible with good resolution and the results of analysis have been validated with correlation coefficient of 0.9990

scholarly journals SIMULTANEOUS ESTIMATION OF LAMIVUDINE, ABACAVIR AND DOLUTEGRAVIR BY UPLC METHOD

2018 ◽  
Vol 10 (1) ◽  
pp. 46
Author(s):  
Somshankar Dubey ◽  
Mahesh Duggirala
Keyword(s):  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Column Temperature ◽  
Limit Of Quantitation ◽  
Photodiode Array ◽  
Acquity Uplc ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Objective: To develop a simple, rapid, sensitive and effective reverse phase ultra-performance liquid chromatographic method (RP-UPLC) for simultaneous quantification of lamivudine, abacavir and dolutegravir in pure and tablet dosage forms.Methods: Chromatographic separation was performed by using Waters-ACQUITY UPLC system equipped with auto sampler, photodiode array (PDA) detector, zodiac sil RP C18 (4.6 mm × 250 mm, 3.0 µm) column, phosphate buffer (pH 3.0) and methanol in the ratio of 30:70 %v/v have been delivered at a flow rate of 0.25 ml/min and the detection was carried out using a Ultraviolet (UV) detector at a wavelength of 260 nm at ambient column temperature. The mobile phase was used as diluent.Results: The retention time (Rt) for lamivudine, abacavir and dolutegravir were 1.763, 2.247 and 3.175 min respectively. A good linear response was obtained in the range of 15-75 µg/ml, 30-150 µg/ml and 2.5-12.5 µg/ml, respectively. The Limit of Detection (LOD) values were found to be 0.021, 0.330 and 0.038 µg/ml, respectively and the Limit of Quantitation (LOQ) values were 0.056, 1.320 and 0.095 µg/ml, respectively.Conclusion: It was concluded that the developed RP-UPLC method was effective, suitable and conducive for analyzing lamivudine, abacavir and dolutegravir in pharmaceutical formulations. The method was quantitatively evaluated in terms of precision, linearity, accuracy (recovery), selectivity and robustness in accordance with standard guidelines.

scholarly journals DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF BAMIFYLLINE HYDROCHLORIDE IN TABLET DOSAGE FORM

2017 ◽  
Vol 9 (4) ◽  
pp. 76
Author(s):  
Panchumarthy Ravisankar ◽  
Shaheem Sulthana ◽  
Inturi Mary Thanuja ◽  
A. Dihitha Chowdary ◽  
J. Vyshnavi
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Array Detector ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Photodiode Array Detector ◽  
Limit Of Quantitation ◽  
Tablet Dosage

Objective: The objective of the current study was to develop and validate a novel RP-HPLC method for determination of bamifylline hydrochloride in pharmaceutical dosage form.Methods: Chromatographic separation was conducted on Agilent technologies-1260 series with the G1311C quaternary pump, eclipse XDB C18 column (4.6 mm i.d. X 250 mm, 5 µm particle sizes) and equipped with photodiode array detector G1315D. Mobile phase consisted of methanol and acetonitrile were mixed in the ratio of 90:10 v/v, was used at a flow rate of 1 ml/min and detection wavelength was set at 263 nm.Results: The retention time for bamifylline hydrochloride was found to be 2.913 min. The calibration was linear (r2= 0.9996) in the concentration range of 2-10 µg/ml. The limit of detection and the limit of quantitation were found to be 0.4825 μg/ml and 1.4621 µg/ml respectively. Recovery of bamifylline hydrochloride in tablet formulation was observed in the range of 99.6-99.8 %. Percentage assay of bamifylline hydrochloride (Bamifix) was found to be 99.4 % w/w.Conclusion: Thus the novel proposed method for bamifylline hydrochloride was found to be feasible for the estimation of bamifylline hydrochloride in bulk as well as a pharmaceutical dosage form. 

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.

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