scholarly journals DEVELOPMENT AND VALIDATION OF DOUBLE DIVISOR RATIO SPECTRA DERIVATIVE SPECTROPHOTOMETRY METHOD FOR TERNARY MIXTURE OF DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PSEUDOEPHEDRINE HYDROCHLORIDE IN TABLET DOSAGE FORM

2020 ◽  
pp. 249-252
Author(s):  
RIDA EVALINA TARIGAN ◽  
MUCHLISYAM ◽  
SITI MORIN SINAGA ◽  
ZUL ALFIAN
Keyword(s):  
Ternary Mixture ◽  
Dosage Form ◽  
Acceptable Range ◽  
Validation Parameters ◽  
Recovery Study ◽  
The Mean ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Dextromethorphan Hydrobromide

This study aimed to develop spectrophotometry method by double divisor ratio spectra derivative to determine the levels of dextromethorphan hydrobromide (DEX), doxylamine succinate (DOX) and pseudoephedrine hydrochloride (PSE) in tablet dosage form using ethanol as solvent. The method is based on the use of the coincident spectra of the derivative of the ratio spectra obtained using a double divisor and measuring at the wavelengths selected. Then, the method was applied to determine the levels of DEX, DOX and PSE in tablet dosage form. The selected wavelengths for determination of DEX, DOX and PSE are 277.0 nm, 243.0 nm, and 243.2 nm, respectively. The mean % recoveries were found to be in 100.88%, 100.05%, and 100.26% for DEX, DOX and PSE, respectively. The method is successfully applied to analyze DEX, DOX and PSE in pharmaceutical formulation with no interference from excipients as indicated by the recovery study. All validation parameters were within the acceptable range.

scholarly journals DEVELOPMENT AND VALIDATION OF DOUBLE DIVISOR RATIO SPECTRA DERIVATIVE SPECTROPHOTOMETRY METHOD FOR TERNARY MIXTURE OF GUAIFENESIN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL IN TABLET DOSAGE FORM

2018 ◽  
Vol 11 (13) ◽  
pp. 1
Author(s):  
Fitria Adriani ◽  
Muchlisyam Muchlisyam ◽  
Siti Morin Sinaga
Keyword(s):  
Dosage Form ◽  
Derivative Spectrophotometry ◽  
Diphenhydramine Hydrochloride ◽  
Validation Parameters ◽  
Recovery Study ◽  
The Mean ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Selection Of

 Objective: This study aimed to develop spectrophotometry method by double divisor ratio spectra derivative to determine the levels of guaifenesin (GUA), dextromethorphan hydrobromide (DMP), and diphenhydramine hydrochloride (DPH) in tablet dosage form using ethanol as solvent.Methods: The method is based on the use of the coincident spectra of the derivative of the ratio spectra obtained using a double divisor (sum of two spectra) and measuring at either the maximum or minimum wavelengths. Then, the method was applied to determine the levels of GUA, DMP, and DPH in tablet dosage form.Results: The application of double divisor ratio spectra derivative spectrophotometry method for the determination of GUA, DMP, and DPH was performed on the first derivative at Δλ 2 (λ 280.0 nm, λ 286.1 nm, and 260.2 nm, respectively). The selection of wavelengths based on wavelengths gives the best result. The mean % recoveries were found to be in 100.60%, 99.95%, and 101.74% for GUA, DMP, and DPH, respectively.Conclusion: The method is successfully applied to analyze GUA, DMP, and DPH in pharmaceutical formulation with no interference from excipients as indicated by the recovery study. All validation parameters were within the acceptable range.

METHOD DEVELOPMENT AND VALIDATION OF VALACYCLOVIR HYDROCHLORIDE AND RITONAVIR IN TABLET DOSAGE FORM USING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

2015 ◽  
Vol 76 (1) ◽  
Author(s):  
D. Sathis Kumar ◽  
B. D. N Prashanthi ◽  
A. Harani ◽  
P. Anusha
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Water Mixture ◽  
Method Development And Validation ◽  
The Mean ◽  
Development And Validation ◽  
Tablet Dosage

Our main objective is to develop an accurate and precise RP-HPLC method for the simultaneous determination of Valacyclovir HCl and Ritonavir in tablet dosage form. An Agilent TC-C18 (2) column is used for the Separation of drugs by a mobile phase consisting of methanol, acetonitrile and water mixture in the ratio of 35:41.5:23.5v/v. The flow rate maintained was 1.3 mL/min and the wavelength used for detection was 222 nm. The linearity was observed in the range of 12.5-125µg/ml for Valacyclovir HCl (VC) and Ritonavir (RT) with a correlation coefficient of 0.9987 and 0.9981 respectively. The mean percentage recoveries for 80%, 100% and 120% accuracy were found to be 101.7%±2.09, 100%±2.49 and 101.5%±1.61 respectively for VC. The mean percentage recoveries for 80%, 100% and 120% accuracy were found to be 104.3%±0.99, 100%±1.77and 99.0%±1.22 respectively for RT. Linearity, accuracy, precision and robustness parameters for the suggested method were estimated for validation. The developed method can be utilized in the analysis of VC and RT tablets.

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF FAMOTIDINE, DICLOFENAC AND PARACETAMOL IN THEIR COMBINED DOSAGE FORM

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (09) ◽  
pp. 60-64
Author(s):  
P. P Desai ◽  
◽  
N. R. Patel ◽  
H. G Bhatt
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Simultaneous Equation ◽  
Simultaneous Estimation ◽  
Absorbance Measurement ◽  
Validation Parameters ◽  
Stock Solutions ◽  
Development And Validation ◽  
Tablet Dosage

Famotidine (FAM), Diclofenac (DCF) and Paracetamol (PCM) are used in combination for musculoskeletal disorders. A simple, sensitive, rapid, precise, reproducible and accurate spectrophotometric method for simultaneous determination of FAM, DCF and PCM was developed. The method was based on UV spectrophotometric determination of three drugs using simultaneous equation method. The stock solutions were prepared in methanol AR. Absorbance measurement was carried out at 288.4 nm, 281.2nm and 248.2 nm for FAM, DCF and PCM respectively. Beer Lambert law was obeyed in the concentration range of 1-30μg/mL for FAM, 2-40μg/mL for DCF and 1-20μg/mL for PCM. The results of the analysis were tested and validated for various validation parameters statistically and by recovery studies according to the International Conference on Harmonization Q2B guidelines. The utility of the developed method has been demonstrated by analysis of commercially available tablet dosage form.

scholarly journals RP-HPLC method for simultaneous determination of escitalopram oxalate and flupentixol HCl in tablet dosage form

2021 ◽  
Vol 14 (1) ◽  
pp. 169-174
Author(s):  
Wrushali A. Panchale ◽  
Shivrani W. Nimbokar ◽  
Bhushan R. Gudalwar ◽  
Ravindra L. Bakal ◽  
Jagdish V. Manwar
Keyword(s):  
Simultaneous Determination ◽  
Dosage Form ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Recovery Study ◽  
Tablet Dosage

RP-HPLC method was developed for simultaneous determination of escitalopram oxalate (ESC) and flupentixol HCl (FLU) in tablet dosage form. Mobile phase consisting of mixture of acetonitrile and potassium phosphate buffer (pH 7.0 with 0.1% triethylamine) in the ratio 60: 40 at flow rate of 1ml/min using C18 Grace (250mmX 4.6mm) column at 231 nm. The retention time of ESC with FLU was found to be 2.96 min and 6.98 min, respectively. The linearity range for ESC with FLU observed was 5-25 µg/ml and 10-50 µg/ml, respectively. Method was validated as per ICH guidelines. Validation parameters studied were linearity and range, recovery study, precision, LOD, LOQ and robustness. Statistical data obtained was found to satisfactorily.

scholarly journals DETERMINATION OF THIAMINE HCL (VITAMIN B1) AND PYRIDOXINE HCL (VITAMIN B6) CONTENT IN TABLET BY FTIR

2016 ◽  
Vol 8 (10) ◽  
pp. 257 ◽  
Author(s):  
Ilma Nugrahani ◽  
Citra Kartini
Keyword(s):  
Vitamin B6 ◽  
Dosage Form ◽  
Vitamin B1 ◽  
Area Under The Curve ◽  
Thiamine Hydrochloride ◽  
Compound Identification ◽  
Quantitation Limit ◽  
Validation Parameters ◽  
Tablet Dosage

<p><strong>Objective: </strong>The combination of thiamine hydrochloride (vitamin B1) with pyridoxine hydrochloride (vitamin B6) has been efficacious to help the metabolism of carbohydrates and amino acids. FTIR (Fourier transform infrared) is a technique widely used in compound identification and determination of functional groups but rarely used for the quantitative purposes. This study aims to obtain a analysis determination method of this vitamin combination simultaneously in tablet dosage form using FTIR.</p><p><strong>Methods: </strong>Amount of vitamin B1 and B6 standard were mixed with KBr crystal in a series of concentration (% w/w) in kalium bromide (kbr) crystal, then measured with FTIR. These spectrums yielded were transformed into an absorbance afterward changed to its derivative. The finest spectrum, which showed the best specificity and linearity, was selected and its area under the curve was calculated. The other validation parameters: accuracy, precision, detection limit, quantitation limit, and ranges, next were tested and determined. The validated method than was used to analyze the levels of vitamin B1 and B6 simultaneously in the tablets.</p><p><strong>Results: </strong>Vitamin B1 and B6 have the linear concentration range from 0.5 to 3.00% w/w. The regression equation for vitamin B1 is y = 0.0608 x-0.0176 with r = 0.9997 and Vx0 = 1.5047%, for vitamin B6: y = 0.0977 x+0.0079 r = 0.9995 and Vx0 = 1.7832%. Recovery results of vitamin B1: 98.98 to 100.93%, while B6: 99.06 to 100.43%. Intra-day and inter-day precision for vitamin B1: 1.73; 1.62; 1.48, and 0.58%, meanwhile for vitamin B6: 1.29; 1.60; 1.78, and 1.39%. The limits of detection and quantitation for vitamin B12 was 0.079 and 0.263% w/w respectively, and for vitamin B6, was: 0.093 and 0.311% w/w. The tablets from the market were tested showed the results that meet with compendia requirements.</p><p><strong>Conclusion: </strong>FTIR can be used for the determination of levels of vitamin B1 and B6 simultaneously in tablet dosage form and have met the validation requirements.</p>

scholarly journals DETERMINATION OF CHROMATOGRAPHIC ASSAY AND VALIDATION OF OFLOXACIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

2018 ◽  
Vol 11 ◽  
Author(s):  
Sumithra M
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Assay Method ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
The Mean

Objective: The objective of the study is simple, sensitive; eco-friendly reverse phase chromatographic method has been developed and validated for the quantitative determination of ofloxacin in bulk and marketed formulation. Method: The developed method was done using Hypersil silica C18 (250 mm × 4.6 mm, 5 μ particle size) as column and the mobile phase is containing water and methanol in the ratio of (10:90) vol/vol. The mobile phase pass at 1 ml/min flow rate and the eluted solution is measured at 270 nm using a PDA detector. Results: The assay method is linear from the concentration range of 5–30 μg/ml. The corelation coefficient is 0.9998. The mean percentage recovery for the developed method is found to be in the range of 98.4–100.6%. The developed method complies robustness studies. Conclusion: The validation of the developed method was done by as per the ICH guidelines. It obeys the linearity, accuracy, precision, and robustness studies. Validation parameters are within the limitations. The results of the developed process indicated the reverse phase chromatographic method is simple, accurate as well as precise, rapid and eco-friendly method for routine analysis of ofloxacin in bulk and its pharmaceutical dosage form.

scholarly journals Development and validation of RP-HPLC method for determination of Atorvastatin calcium and Nicotinic acid in combined tablet dosage form

2016 ◽  
Vol 20 ◽  
pp. S328-S333 ◽  
Author(s):  
Jaiprakash N. Sangshetti ◽  
Mohammed Aqeel ◽  
Zahid Zaheer ◽  
Rana Z. Ahmed ◽  
M.H.G. Dehghan ◽  
...  
Keyword(s):  
Nicotinic Acid ◽  
Dosage Form ◽  
Hplc Method ◽  
Atorvastatin Calcium ◽  
Rp Hplc ◽  
Development And Validation ◽  
Tablet Dosage

scholarly journals Development DEVELOPMENT AND VALIDATION OF NOVEL ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF DALFAMPRIDINE IN BULK AND IN PHARMACEUTICAL FORMULATION

2019 ◽  
pp. 275-279
Author(s):  
VAIBHAV S KHODKE ◽  
GAME MD
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Quantitative Estimation ◽  
Spectroscopic Method ◽  
Quality Criteria ◽  
Pharmaceutical Dosage Form ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Good Agreement

Objective: The objective of the present study is to develop ultraviolet (UV)-spectroscopic method using pure drug and tablet dosage form that consistently produces a drug with a minimal variation that adheres to quality criteria of purity, identity, and potency. Methods: UV-spectrophotometric method has been developed using a solvent composed of methanol:water (30:70) as a diluent to determine the dalfampridine (DFP) content in bulk and pharmaceutical dosage form at predetermined λmax of 262 nm. Results: It was proved linear in the range of 02–12 μg/ml and exhibited a good correlation coefficient (r2 = 0.9915) and excellent mean recovery (0.004136347%). This method was successfully applied to the determination of DFP content of marketed tablet Dalstep 10 mg (Sun Pharmaceutical Pvt. Ltd.,) from India; the results were in good agreement with the label claims. Conclusion: The method proved to be simple, accurate, precise, specific, robust, and less time consuming and can be applied for the determination of DFP in bulk and marketed formulation.

scholarly journals NOVEL UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF TERIFLUNOMIDE IN TABLET DOSAGE FORM

2019 ◽  
pp. 81-84
Author(s):  
VISHWAS T. S. ◽  
GURUPADAYYA B. M.
Keyword(s):  
Linear Relationship ◽  
Spectrophotometric Method ◽  
Calibration Curve ◽  
Dosage Form ◽  
Current Work ◽  
Validation Parameters ◽  
Line Equation ◽  
Tablet Dosage ◽  
Ich Guideline

Objective: The current work is intended towards the development of a novel, simple, and precise UV spectrophotometric method for the estimation of teriflunomide (TEF) present in the marketed formulation. Methods: Acetonitrile was used as asolvent and the absorbance of the drug was measured at the absorbance maxima of TEF, UV 284 nm. Results: Calibration curve plotted in concentration range 5-10 µg /ml exhibited excellent linear relationship with line equation y = 0.0858x-0.0223 and r2 value of 0.9996. The method was found to comply all the validation parameters as per the ICH guideline indicating the sensitivity of the method towards analyte. Conclusion: The method can be used satisfactorily for the routine analysis of TEF present in marketed formulation.

METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF PIOGLITAZONE IN BULK SAMPLES AS WELL AS IN TABLET DOSAGE FORMS BY USING RP -HPL C

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (09) ◽  
pp. 42-46
Author(s):  
M Debnath ◽  
◽  
A. S. Kumar ◽  
V. D. S Ganta
Keyword(s):  
Method Development ◽  
Dosage Forms ◽  
Hplc Method ◽  
Uv Detector ◽  
Pharmaceutical Dosage Forms ◽  
Method Development And Validation ◽  
The Mean ◽  
Development And Validation ◽  
Tablet Dosage

A simple and precise RP‐HPLC method was developed and validated for the determination of pioglitazone hydrochloride in pharmaceutical dosage forms. Chromatography was carried out using Kromosil- C18 ODS column (250 x 4.6 mm; 5 μm), mixture of acetate buffer: methanol (40:60 v/v) as the mobile phase at a flow rate 1.0 mL/min. The analyte was monitored using UV detector at 254 nm. The retention time for pioglitazone HCl was 3.063 min. The proposed method was found linear in the concentration range of 20.0‐70.0 μg/ml with correlation coefficient of r2=0.9999. The developed method has been statistically validated and found simple and accurate. The mean recoveries obtained for pioglitazone HCl were in the range 99.20-101.59%. Due to its simplicity, rapidness, high precision and accuracy of the proposed method it may be used for determining pioglitazone HCl in bulk and dosage forms.

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