scholarly journals Development and Characterization of a Combination Tablet Dosage Form Containing Sofosbuvir and Ribavirin Using Design of Experiments (DoE) Approach

2021 ◽  
Vol 20 (1) ◽  
pp. 121-133
Author(s):  
Md Anisul Islam ◽  
Md Mahbubul Alam ◽  
KM Yasif Kayes Sikdar ◽  
ASM Monjur Al Hossain ◽  
Abu Shara Shamsur Rouf
Keyword(s):  
Design Of Experiments ◽  
Dosage Form ◽  
Hcv Infection ◽  
Contour Plot ◽  
Disintegration Time ◽  
Combination Tablet ◽  
Pharmaceutical Dosage Form ◽  
Factors Affecting ◽  
Two Factors ◽  
Tablet Dosage

Worldwide more than 180 million people get infected by chronic Hepatitis C Virus (HCV) and around 700,000 people pass away every year due to HCV related problems. Sofosbuvir and Ribavirin are prescribed as combined medication for the management of HCV infection globally. Therefore, optimization of a pharmaceutical dosage form containing Sofosbuvir and Ribavirin can open a new hope in the treatment of HCV infection. This study was conducted by using the Design of Experiments (DoE) approach. It is a systematic process aiming to determine the correlation between formulation factors affecting the approach and the output of the approach. During the development of formulations, two factors were considered, which are Croscarmellose Sodium (CCS) and Povidone K30 (PK30) at different concentrations ranging from 0.19% to 2.31% of the total tablet weight in 9 different formulations. Their effect on disintegration time (DT) was evaluated through statistical method and it was found between 3±0.003 and 6.5±0.015 minutes. The use of these two different disintegrants exhibited a significant effect on DT. The contour plot showed predicted ranges of concentrations of CCS and PK30 for desired DT. Fourier Transform Infrared Spectroscopy (FTIR) data, Thermogravimetric Analysis (TGA) and X-ray Diffractometry (XRD) spectrums confirmed that there was no interaction between Sofosbuvir and Ribavirin or with any other excipients used in this experiment. Dhaka Univ. J. Pharm. Sci. 20(1): 121-133, 2021 (June)

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.

A VALIDATED METHOD FOR THE DETERMINATION OF TAPENTADOL HYDROCHLORIDE IN BULK AND ITS PHARMACEUTICAL FORMULATION BY DENSITOMETRIC ANALYSIS

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (12) ◽  
pp. 51-55
Author(s):  
S Kathirvel ◽  
◽  
K. Madhu Babu
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Glacial Acetic Acid ◽  
Calibration Plot ◽  
Pharmaceutical Dosage Form ◽  
Aluminum Plates ◽  
Tablet Dosage

Described in this manuscript is the first reported new, simple high performance thin layer chromatographic method for the determination of tapentadol hydrochloride in bulk and its tablet dosage form. The drug was separated on aluminum plates precoated with silica gel 60 F254 with butanol: water: glacial acetic acid in the ratio of 6:2:2 (v/v/v) as mobile phase. Quantitative analysis was performed by densitometric scanning at 254 nm. The method was validated for linearity, accuracy, precision and robustness. The calibration plot was linear over the range of 200-600 ng band -1 for tapentadol hydrochloride. The method was successfully applied to the analysis of drug in a pharmaceutical dosage form.

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.

SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND INDAPAMIDE BY DUAL WAVELENGTH SPECTROPHOTOMETRIC METHOD FOR COMBINED PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (04) ◽  
pp. 50-54
Author(s):  
M. P Patel ◽  
◽  
M. R Patel ◽  
R Hasumati ◽  
M. N Noolvi ◽  
...  
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Dual Wavelength ◽  
Simultaneous Estimation ◽  
Uv Spectrophotometry ◽  
Amlodipine Besylate ◽  
Pharmaceutical Dosage Form ◽  
First Order ◽  
Absorbance Difference ◽  
Tablet Dosage

A simple, accurate, precise, rapid, economical UV spectrophotometry method, dual wavelength spectrophotometry, has been developed and validated for estimation of Indapamide (IND) and Amlodipine besylate (AML) in combined tablet dosage form and can be used in routine analysis. In this method, the absorbance at 360 nm and 256 nm of AML were same and no interference of IND at 360 nm. was observed. So, absorbance difference at 256-360 is used for estimation of IND and absorbance at 360 nm used for AML. The method was found to be linear in the concentration range of 3-18 μg/mL for IND (r2>0.99962) and 10-60 μg/mL for AML (r2>0.99969). Mean assay was found to be 99.32% and 101.34% for IND and AML respectively. In first order derivative spectrophotometry, the absorbance at 237.4 nm (ZCP of AML) and 241 nm (ZCP of IND) were used for estimation of IND and AML respectively. The method was found to be linear in the concentration range of 1.5-9 μg/mL for IND(r2=0.99983) and 5-30 μg/mL for AML(r2=0.99966). Mean assay was found to be 99.72% and 100.28% for IND and AML respectively.

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.

A Validated Stability Indicating RP-HPLC Method for the Estimation of an Anti-Cancer Drug Regorafenib in Pure and Pharmaceutical Dosage Form

2017 ◽  
Vol 4 (1) ◽  
pp. 5-10 ◽  
Author(s):  
Ramesh Jayaprakash ◽  
Senthil Kumar Natesan
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Cancer Drug ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, economic, accurate, sensitive, specific and precise stability indicating reverse phase high performance liquid chromatographic [RP-HPLC] method for the determination of Regorafenib in pure and tablet dosage from was developed and validated. The chromatographic separation was carried out using Phenomenex Luna-C18 column (4.5x250 mm; 5 µm particle size) as a stationary phase and methanol: acetonitrile: water (55:25:20 v/v/v) as a mobile phase. The flow rate of 1 mL/min was used with PDA detection at 275 nm. The retention time of Regorafenib was 2.480 min. RP-HPLC method was developed with linearity range of 40-240 µg/mL of Regorafenib. The correlation coefficient [r2] was found to be 0.9999. The assay results obtained was in good agreement with the corresponding labeled amount by developed method within range of 98.83 ± 0.6937. Accuracy of the method was confirmed by recovery studies and the recoveries were found to be between 99.61 % and 100.22 %, the corresponding %RSD was found to be 0.2029. Precision, LOD, LOQ, specificity, robustness and ruggedness were performed as per ICH Q2(R1) guidelines and were within the acceptance criteria. This method can be conveniently used to detect the possible degradation product in the dosage form of Regorafenib during stability studies (acidic, alkaline, oxidative, thermal and photolytic). The method proved to be effective on the analysis of stressed marketed tablet formulation.

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 Stability indicating RP-HPLC method development and validation for the simultaneous estimation of Grazoprevir and Elbasvir in bulk and pharmaceutical dosage form

2018 ◽  
Vol 1 (1) ◽  
pp. 1-7
Author(s):  
V. Pavan Kumar ◽  
A. Vijaya Kumar ◽  
B Sivagami ◽  
R. Charan Kumar ◽  
M. Niranjan Babu
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Pharmaceutical Dosage Form ◽  
Potassium Hydrogen ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

A simple, Accurate and precise method was developed for the simultaneous estimation of the Grazoprevir and Elbasvir in Tablet dosage form. Chromatogram was run through Kromosil C18 (250 x 4.6 mm), 5m. Mobile phase containing Buffer: Acetonitrile taken in the ratio 45:55 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was Di Potassium Hydrogen ortho Phosphate. Temperature was maintained at 30°C. Optimized wavelength selected was 215 nm. Retention time of Elbasvir and Grazoprevir and were found to be 2.503 min and 3.004. %RSD of the Elbasvir and Grazoprevir were and found to be 0.3 and 0.4 respectively. %Recovery was obtained as 98.17% and 99.83% for Grazoprevir and Elbasvir respectively. LOD, LOQ values obtained from regression equations of Grazoprevir and Elbasvir were 0.24, 0.73 and 0.06, 0.19 respectively. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

scholarly journals A VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PYRANTEL PAMOATE AND PRAZIQUANTEL IN BULK AND PHARMACEUTICAL DOSAGE FORM

2019 ◽  
pp. 62-67 ◽  
Author(s):  
Rajesh R. ◽  
JITHU JERIN JAMES
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Correlation Coefficients ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Pyrantel Pamoate ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Tablet Dosage

Objective: To develop a simple, accurate and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method and subsequently validate for the simultaneous estimation of praziquantel (PZQ) and pyrantel pamoate (PP) in the pharmaceutical dosage form. Methods: The chromatographic separation was achieved on Phenomenex Luna C18 column (250 mm × 4.6 mm, 5 μm) as stationary phase maintained at an ambient temperature with a mobile phase comprising of water: acetonitrile (20: 80) at a flow rate of 1.0 ml/min and UV detection at 220 nm. Results: The retention time of PZQ and PP was found to be 3.897 min and 1.697 min respectively. The method was validated in terms of specificity, accuracy, precision, linearity and robustness as per ICH guidelines. Linearity was obtained in the concentration range of 20–60 μg/ml for both PZQ and PP with correlation coefficients of 0.987 and 0.998 respectively. The accuracy of the method was determined using a recovery test and found as 98.44 % to 100.35 %. All parameters are found to be within the acceptable limit. Conclusion: The developed RP-HPLC method was simple, rapid, accurate, precise for the simultaneous estimation of PZQ and PP in bulk and tablet dosage form.

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF TENELIGLIPTINE HYDROBROMIDE HYDRATE (TEN) AND METFORMIN HYDROCHLORIDE (MET) IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (08) ◽  
pp. 49-56
Author(s):  
H Joshi ◽  
A. Khristi ◽  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Assay Method ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Economic Method ◽  
Hplc Method Development ◽  
Tablet Dosage

A simple, accurate, precise, reproducible and economic method developed and validated for the simultaneous estimation of teneligliptine hydrobromide hydrate (TENE) and metformin hydrochloride (MET HCl) in pharmaceutical dosage form. TENE and MET HCl were estimated on Thermoscientific C18 column using mobile phase 0.01M PDP: methanol (45:55 % v/v) (pH 3.5 adjusted with 5% acetic acid) at flow rate 1.0 mL/min. Detection was carried out at 254 nm. The retention time of teneligliptine hydrobromide hydrate and metformin hydrochloride were 7.77 min and 2.64 min, respectively. The linearity was found to be 4-12 μg/mL and 100-300 μg/mL for TENE and MET HCl respectively. R2 value was found to be 0.998 and 0.995. For the assay method % recovery was found in the range of 98.16 – 101 for TENE and MET HCl. The LOD and LOQ were found to be 0.3527 and 1.0690 for TENE and 0.5077 and 1.538 for MET HCl respectively. Method was validated as per ICH guidelines.

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