Stability Indicating Assay Method Development and Validation of Simultaneous Estimation of Chlorzoxazone, Diclofenac Sodium and Paracetamol in Bulk Drug and Tablet by RP-HPLC

2021 ◽  
pp. 5024-5028
Author(s):  
Krutika Patel ◽  
Sudheer Kumar Verriboina ◽  
S.G. Vasantharaju
Keyword(s):  
Method Development ◽  
Diclofenac Sodium ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Assay Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Bulk Drug

A simple, accurate, specific and stability-indicating RP-HPLC method was developed for simultaneous determination of chlorzoxazone, diclofenac sodium and paracetamol, using C18 Vydac Monomeric 120A (250 × 4.6mm, 5μ) at 40ºC. The mobile phase contains a mixture of 20mM potassium dihydrogen phosphate buffer (pH 6.2 adjusted with potassium hydroxide) and acetonitrile (30:70 v/v). The flow rate was 1ml/min and detection was carried out at 275nm using PDA detector. The retention time of paracetamol, chlorzoxazone and diclofenac sodium were 3.28mins, 13.27mins and 15.61mins respectively. The analytical curve was linear over a concentration range of 0.65- 6.5μg/ml for paracetamol, 1-10μg/ml for chlorzoxazone and 0.1-1μg/ml for diclofenac sodium. The drugs in bulk and tablet were subjected to acid and alkali hydrolysis, oxidation, thermal and photolytic degradation. This method can be successfully employed for simultaneous quantitative analysis of Chlorzoxazone, Diclofenac sodium and Paracetamol in bulk drug and tablet formulation.

scholarly journals STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF VILDAGLIPTIN AND METFORMIN IN PHARMACEUTICAL DOSAGE FORM

2017 ◽  
Vol 9 (3) ◽  
pp. 150
Author(s):  
Ramesh Jayaprakash ◽  
Senthil Kumar Natesan
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc

Objective: The present study was aimed to develop a rapid, accurate, linear, sensitive and validate stability-indicating high performance liquid chromatographic [RP-HPLC] method for determination of vildagliptin and metformin in pharmaceutical dosage form.Methods: The chromatographic separation was performed on kromasil-C18 column [4.5 x 250 mm; 5 µm] using a mobile phase consisting of 0.05 mmol potassium dihydrogen phosphate buffer: acetonitrile [80:20 v/v], [pH adjusted to 3.5 using orthophosphoric acid]. The flow rate is 0.9 ml/min and the detection was carried out at 263 nm.Results: The chromatographic condition, the peak retention time of metformin and vildagliptin were found to be 2.215 min and 2.600 min respectively. Stress testing was performed in accordance with an international conference on harmonization [ICH] Q1A R2 guidelines. The method was validated as per ICH Q2 R1 guidelines. The calibration curve was found to be linear in the concentration range of 5-17.5 µg/ml and 50-175 µg/ml for vildagliptin and metformin. The limit of detection and quantification was found to be 0.0182 µg/ml and 0.0553 µg/ml for vildagliptin and 0.4451 µg/ml and 1.3490 µg/ml for metformin respectively.Conclusion: A new sensitive, simple and stability indicating reverse-phase high-performance liquid chromatography [RP-HPLC] method has been developed and validated for the determination of vildagliptin and metformin. The proposed method can be used for routine determination of vildagliptin and metformin.

scholarly journals RP-HPLC method development and validation for the estimation of antifungal drug terbinafine HCL in bulk and pharmaceutical dosage form

2018 ◽  
Vol 1 (1) ◽  
pp. 8-12
Author(s):  
R Sireesha ◽  
P Syam Vijayakar ◽  
V Pavan Kumar ◽  
B Sivagami ◽  
Pranabesh Sikdar ◽  
...  
Keyword(s):  
Method Development ◽  
Quantitative Estimation ◽  
Potassium Dihydrogen Phosphate ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Form ◽  
Terbinafine Hydrochloride ◽  
Rp Hplc ◽  
Bulk Drug

In the present work RP-HPLC method has been developed for the quantitative estimation of Terbinafine hydrochloride in bulk drug and pharmaceutical formulations. A rapid and sensitive RP-HPLC Method with PDA detection (220 nm) for routine analysis of in Bulk drug and Pharmaceutical formulation was developed. Chromatography was performed with mobile phase containing a mixture of Potassium dihydrogen phosphate and Acetonitrile (65:35 v/v) with flow rate 1.5 ml/min. The linearity was found to be in the range of 50-150 µg/ml with (r2=0.999). The proposed method was validated by determining sensitivity, accuracy, precision, LOD, LOQ and system suitability parameters according to ICH guidrelines.

scholarly journals Stability-Indicating RP-HPLC Method for Assay of Silver Lactate

2011 ◽  
Vol 8 (2) ◽  
pp. 483-490
Author(s):  
V. Srinivasan ◽  
H. Sivaramakrishnan ◽  
B. Karthikeyan
Keyword(s):  
Thermal Stress ◽  
Degradation Products ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Stress Conditions ◽  
Base Hydrolysis ◽  
Assay Method ◽  
Dihydrogen Phosphate ◽  
Stability Indicating ◽  
Rp Hplc

A simple, economic and time-efficient stability-indicating, reverse-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for analysis of silver lactate in the presence of degradation products generated by decomposition. When silver lactate was subjected to acid hydrolysis, base hydrolysis, oxidative, photolytic, humidity and thermal stress, degradation was observed during base hydrolysis, oxidation, humidity and thermal stress. The drug was found to be stable to other stress conditions. Successful chromatographic condition of the drug from the degradation products formed under stress conditions was achieved on a phenomenex Gemini column with potassium dihydrogen phosphate buffer, pH adjusted to 2.2 with orthophosphoric acid, as mobile phase. The method was validated for linearity, precision, specificity and robustness and can be used for quality-control during manufacture and assessment of the stability of samples of silver lactate. To the best of our knowledge, a validated stability-indicating LC assay method for silver lactate based on lactic acid is reported for the first time.

scholarly journals Stability indicating RP-HPLC method development and validation for the simultaneous determination of Sofosbuvir and Velpatasvir in tablet dosage forms

2017 ◽  
Vol 5 (04) ◽  
pp. 10-16 ◽  
Author(s):  
Jahnavi Bandla ◽  
S. Ganapaty
Keyword(s):  
Mobile Phase ◽  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Hplc Method Development ◽  
Tablet Dosage

Stability indicating RP-HPLC method was developed for the simultaneous quantitation of Sofosbuvir and Velpatasvir in its pharmaceutical dosage form and validated. The drugs were separated on Discovery C18 (150mm x 4.6mm, 5μ) column using 0.01N potassium dihydrogen phosphate buffer and acetonitrile (50:50%v/v) as mobile phase on isocratic mode. The mobile phase is pump into the column at flow rate of 1.0ml/min and column oven temperature is maintained at 30ºC. The drugs were detected at a wavelength 240nm. The retention time for Sofosbuvir and Velpatasvir were found to be 2.32min and 3.34min respectively. The developed method is validated in accordance with ICH guidelines. The method was found to be accurate, precise, specific and robust. The method obeys Beer’s law at a concentration range of 100μg/ml – 600μg/ml of Sofosbuvir and 25μg/ml – 150μg/ml of Velpatasvir, with correlation coefficient of 0.999 for both the drugs. The drugs were found to be stable and less prone to degradation when they are subjected to various stress conditions.

Simultaneous Estimation and Validation of Tenofovir Disoproxil Fumarate, Emtricitabine and Efavirenz by RP-HPLC Method in Combined tablet Dosage Form

2019 ◽  
Vol 15 (6) ◽  
pp. 561-567 ◽  
Author(s):  
Mehdi Rezaei ◽  
Ali Ramazani ◽  
Fahimeh Hokmabadi
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Dosage Form ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Assay Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Rp Hplc ◽  
Successful Separation ◽  
Tablet Dosage

Introduction: The purpose of this study is the development and validation of assay test for Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC) and Efavirenz (EFV) in combined tablet dosage form by Reverse Phase (RP) HPLC. Materials and Methods: The assay method by HPLC was found to be linear in the concentration range of 15-150 µg/mL, 10-100 µg/mL and 30-300 µg/mL for TDF, FTC, and EFV, respectively. Successful separation of combined drugs was achieved by isocratic elution on a Phenomenex® C8 column (250 mm × 4.6 mm, 5µm). The mobile phase was composed of buffer pH: 7.0 ± 0.05 potassium dihydrogen phosphate, acetonitrile and methanol (40:40:20 v/v) at the flow rate of 1 mL/min using UV detection at 262 nm, column oven temperature 25ºC, and injection volume 20 µL. Results: The analytical results were validated by recovery studies. All the parameters of validation were in the acceptance range. This developed method was successfully applied for simultaneous estimation the amount of TDF, FTC and EFV in the bulk and marketed dosage forms.

scholarly journals RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE COMBINATION OF IMIQUIMOD AND SALICYLIC ACID

2020 ◽  
pp. 41-48
Author(s):  
ANKITA SHARMA ◽  
INDER KUMAR ◽  
KARAN RANA
Keyword(s):  
Salicylic Acid ◽  
Method Development ◽  
Limit Of Detection ◽  
Potassium Dihydrogen Phosphate ◽  
Gradient Elution ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Limit Of Quantification ◽  
Rp Hplc

Objective: The present study was undertaken to develop and validate an RP-HPLC method for the combination of imiquimod and salicylic acid Methods: The method was carried out on Nucleodur C18 (250 mm × 4.6 mm I.D., 5 ????m) using low-pressure gradient elution mode. The mobile phase was used as 30M potassium dihydrogen phosphate and acetonitrile (45:55) pH 6.5 adjusted using ortho-phosphoric acid. The concentration of solvents was 1-20 µg/ml and the volume of injection was 20 mcl with the flow rate of 1.0 ml/min. The absorption maxima of salicylic acid and imiquimod were found 234 nm and 226 nm, respectively. Results: The method was validated and showed the linearity greater than 0.99% and with precision (RSD%<1). The limit of detection (LOD) and limit of quantification (LOQ) of salicylic acid was found to be 0.09756 µg/ml and 0.2956 µg/ml, respectively, and imiquimod was found to be 0.044031 µg/ml and 0.13334 µg/ml, respectively. Conclusion: The method developed in the present study was found to be sensitive, specific, and can be applied for the simultaneous estimation of imiquimod and salicylic acid.

scholarly journals STABILITY INDICATING RP-HPLC ASSAY METHOD FOR ESTIMATION OF DIMETHYL FUMARATE IN BULK AND CAPSULES

2017 ◽  
Vol 9 (5) ◽  
pp. 121 ◽  
Author(s):  
Hemant K. Jain ◽  
Archana A. Gunjal
Keyword(s):  
Dimethyl Fumarate ◽  
Hplc Method ◽  
Assay Method ◽  
Forced Degradation ◽  
Dihydrogen Phosphate ◽  
Column Temperature ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies

Objective: To develop an accurate, simple, precise and specific stability indicating RP-HPLC method for estimation of dimethyl fumarate in bulk and capsules.Methods: An Inertsil ODS (150x4.6 mm, 5µ) column and a mobile phase containing acetonitrile: potassium dihydrogen phosphate buffer pH 6.8 (50:50% v/v) was used for this study. The flow rate was maintained at 1.0 ml/min; column temperature was fixed at 35 °C and UV detection was carried out at 210 nm. The forced degradation studies were performed and method was validated with as per ICH guidelines.Results: The retention time of dimethyl fumarate was found to be 3.3±0.02 min. The value of correlation coefficient between peak area and concentration was found to be 0.9993. The mean percent recovery of dimethyl fumarate in capsules was found in the range of 99.65 to 101.64%. The results of forced degradation studies indicated that the drug was found to be stable in basic, oxidative and thermal conditions while degraded in acidic conditions.Conclusion: It can be conducted from results that the developed HPLC method is simple, accurate, precise and specific. Results of stress testing study revealed that the method is stability indicating. Thus, this method can be used for routine analysis of dimethyl fumarate capsules and check their stability.  

scholarly journals AN INNOVATIVE METHOD DEVELOPMENT AND FORCED DEGRADATION STUDIES FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND LEDIPASVIR BY RP HPLC

2018 ◽  
pp. 34-41
Author(s):  
B. Anjaneyulu Reddy ◽  
Md. Irshad Alam ◽  
Nazia Khanam ◽  
P. R. Adhakrishnanand
Keyword(s):  
High Performance ◽  
Method Development ◽  
Cost Effective ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Combination Tablet ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Effective Stability

Objective: To develop an innovative, rapid, simple, cost effective, stability indicating reverse phase-high performance liquid chromatography (RP-HPLC) method for simultaneous estimation of ledipasvir (LP) and sofosbuvir (SB) in combination pill dosage form. Methods: The method was developed using C8 column, 250 mm x 4.6 mm, 5mm using mobile section comprising of 0.1% (v/v) orthophosphoric acid buffer at pH 2.2 and acetonitrile in the ratio of 45:55 that was pumped through the column at a flow rate of 0.8 ml/min. Temperature was maintained at 30 °C, the effluents were monitored at 260 nm with the help of usage of PDA detector. Results: The retention time of LP and SB were found to be 2.246 min and 3.502 min. The approach was found to be linear with the variety of 9-36 µg/ml and 40-240 μg/ml for LP and SB respectively, the assay of estimated compounds were found to be 99.65% and 99.73% w/v for LP and SB respectively. Conclusion: The pressured samples changed into analyzed and this proposed a technique turned into determined to be particular and stability indicating as no interfering peaks of decay compound and excipients were observed. Hence, the approach was easy and economical that may be efficiently applied for simultaneous estimation of both LP and SB in bulk and combination tablet system.

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