RP-HPLC AND HPTLC STABILITY INDICATING ASSAY METHODS FOR IVERMECTIN IN BULK AND TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (03) ◽  
pp. 32-42
Author(s):  
G. P Wani ◽  
◽  
S. B Jadhav
Keyword(s):  
Mobile Phase ◽  
Stress Testing ◽  
Hplc Method ◽  
Rp Hplc ◽  
Assay Methods ◽  
Photo Stability ◽  
Tablet Dosage ◽  
Hptlc Method ◽  
Alkaline Oxidation

Simple, rapid, precise, accurate RP-HPLC and HPTLC methods have been developed and validated for ivermectin in bulk and its marketed formulation. RP-HPLC method for drug was achieved on Grace C18 (250 mm X 4.6 ID, Particle size; 5 μ) column using mobile phase acetonitrile: 10 mM phosphate buffer (95:05 v/v) pH adjusted to 3 with o-phosphoric acid. Detection of drug was done at 245 nm. The retention time was found to be 5.83 min. HPTLC method for ivermectin was accomplished on a precoated silica gel aluminium plate 60F-254 (CAMAG Linomat 5), using toluene: methanol: glacial acetic acid (8:2:0.1 v/v/v) as a mobile phase. The densitometric scanning was performed at 245 nm which showed Rf 0.46 for ivermectin. The stress testing of the drug individually was carried out under acidic, alkaline, oxidation, photo-stability and thermal degradation conditions. The proposed methods were successfully applied for the determination of drug in bulk and its marketed formulation.

scholarly journals Stability indicating RP-HPLC method for the estimation of flucloxacillin sodium in a tablet dosage form

2020 ◽  
Vol 1 (4) ◽  
pp. 95-100
Author(s):  
Sonalika Patro ◽  
S. Harshith Kumar ◽  
M. Barath kumar ◽  
E. Masthaniah ◽  
K. Sairam ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Theoretical Plate ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
System Suitability ◽  
Precision Study ◽  
Tablet Dosage

A Simple, accurate and precise method was developed and validated for the determination of flucloxacillin sodium in its tablet dosage form. The separation was eluted on xterra c18 column (4.6x150mm, 5micron) using a mixture of octane buffer and methanol as mobile phase in a ratio of (30:70) which was pumped through column at a flow rate of  1ml/min. Optimised wavelength for flucloxacillin was 237nm, the retention time was 2.305minutes and the percentage purity was found to be 98.14%. System suitability parameters such as theoretical plate and tailing factor for flucloxacillin sodium was found to be 2991.64 and 1.90 respectively, the proposed method was validated as per ICH guidelines (ICH, Q2 AND (R1)) the method was found to be linear at the concentration range of 20-100µg/ml and the correlation coefficient (r2) value was found to be 0.9994 percentage RSD for precision was 0.9% and percentage RSD for ruggedness was 0.5%. The precision study was precise, robust and repeatable. The LOD and LOQ values are 2.98 and 9.98 respectively. Hence the suggested RP-HPLC method can be used for routine analysis for flucloxacillin sodium in tablet dosage form.

scholarly journals Analytical method validation for estimation of avanafil and dapoxetine hydrochloride tablet dosage form by HPTLC method

2017 ◽  
Vol 4 (3) ◽  
pp. 171 ◽  
Author(s):  
Dhwani A. Shah ◽  
Kunjal L. Vegad ◽  
Ekta D. Patel ◽  
Hitesh K. Prajapati ◽  
Ronak N. Patel ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Analytical Method Validation ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Chloroform Methanol ◽  
Hptlc Method ◽  
Dapoxetine Hydrochloride

Objective: A simple, specific, accurate and precise RP-HPTLC method has been developed and validated for simultaneous estimation of Avanafil and Dapoxetine.Methods: The chromatographic separation was achieved on Aluminium plates precoated with Silica gel 60 F254 using chloroform: methanol: ethyl acetate: glacial acetic acid (5:2:3:0.2, v/v/v/v) as mobile phase detected at 279 nm.Results: The correlation coefficient for RP-HPLC method was found to be 0.9987 for Avanafil and 0.9991 Dapoxetine and the linearity range was found to be 1040-3640 ng*spot-1 for Avanafil and 80-280 ng*spot-1 for Dapoxetine.Conclusions: The developed method was successfully applied to marketed tablet dosage form and the results were found with higher confidence.

scholarly journals SIMULTANEOUS DETERMINATION OF TIGECYCLINE AND ITS POTENTIAL IMPURITIES BY A STABILITY-INDICATING RP-HPLC-UV DETECTION TECHNIQUE

2022 ◽  
pp. 75-82
Author(s):  
V. N. V. KISHORE ◽  
G. V. RAMANA
Keyword(s):  
Flow Rate ◽  
Mobile Phase ◽  
Hplc Method ◽  
Isocratic Elution ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Buffer Mixture ◽  
Bulk Drug ◽  
Tablet Dosage

Objective: Stability representing the RP-HPLC method was established for synchronized quantification of Tigecycline and its impurities. This method was confirmed for its applicability to both tablet dosage and bulk drug forms. Methods: Intended for an isocratic elution, a mobile phase containing methanol: 10 mmol Triethylamine Buffer mixture (75:25 v/v, pH 6.1) was used at 1 ml/min flow rate and Agilent ZORBAX Eclipse XDB C18 (250 mm × 4.6 mm, 5 μm) column. Results: At 231 nm as wavelength, high-pitched peaks of Tigecycline (Tig) and its impurities (1and2) were detected at 6.55, 8.73 and 4.87 min correspondingly. The linearity of tigecycline and its impurities (impurity-1 and 2 and) were estimated with ranging from 75–450 µg/ml for Tigecycline and 1–6 µg/ml for both impurity 1 and 2. The corresponding recognition limits (LOD and LOQ) of the tigecycline and its impurities were originated to be (1.37,0.047 and 0.071 µg/ml) and (4.15, 0.143 and 0.126 µg/ml). Conclusion: The technique was effectively stretched for stability signifying studies under different stress conditions. Justification of the method was done as per the current ICH guidelines.

scholarly journals Stability indicating RP HPLC method for determination of levitiracetam in pharmaceutical formulation

2013 ◽  
Vol 1 (04) ◽  
pp. 45-54 ◽  
Author(s):  
M. Krishna Chaitanya Prasad ◽  
G. Vidhya Sagar ◽  
P. Sudhakar
Keyword(s):  
Stress Testing ◽  
Hplc Method ◽  
Chromatographic Separations ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Photodiode Array ◽  
Standard Calibration ◽  
Tablet Dosage

The article reports on a development of RP-HPLC method for the quantitative determination of Levetiracetam in tablet dosage forms. The chromatographic separations were performed using Phenomenex_ C18 (250 mm x 4.6 mm i.d, 5 μm particle size) column at 40 ºC temperatures. The optimum mobile phase consisted of methanol, water and acetonitrile in the ratio of 30:10:60. Auto sampler 20 μl was used and kept at 15 ºC temperature. Analysis was done with flow rate of 1.0 ml/min at 212 nm (_ max of Levetiracetam) wavelength by using photodiode array (PDA) detector. The drug was analyzed for acid, alkaline, oxidative, hydrolytic, photolytic and thermal degradation studies. The standard calibration curve was plotted for the drug and results showed that the drug was linear (r2 = 0.999) in the concentration range between 0.01 – 1.5 μg/ml. The results of stress testing undertaken according to the International Conference on Harmonization (ICH) guidelines reveal that the selected method is selective and stability-indicating for determination of levitiracetam in pharmaceutical formualtion.

scholarly journals Validated RP-HPLC Method for the Determination of Buspirone in Pharmaceutical Formulations

2011 ◽  
Vol 2011 ◽  
pp. 1-3 ◽  
Author(s):  
M. V. Basaveswara Rao ◽  
A. V. D. Nagendrakumar ◽  
Sushanta Maiti ◽  
Guttikonda Raja
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Isocratic Elution ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Precision And Accuracy ◽  
Tablet Dosage

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the rapid assay of the Buspirone in tablet dosage form. Isocratic elution at a flow rate of 1.0 mL/min was employed on a symmetry C18 (250×4.6 mm, 5 μm in particle size) at ambient temperature. The mobile phase consisted of water : acetonitrile : methanol 45 : 35 : 20(V/V). The UV detection wavelength was 210 nm, and 20 μL sample was injected. The retention time for the Buspirone was 7.057 min. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method can be successfully applied for the routine analysis of Buspirone in tablet dosage form.

RP-HPLC AND HPTLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DOLUTEGRAVIR IN BULK AND TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (05) ◽  
pp. 30-38
Author(s):  
M. R. Ghante ◽  
◽  
S. D Sawant ◽  
M. Undre ◽  
S. G Jagtap ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Strand Transfer ◽  
Rp Hplc ◽  
Transfer Inhibitor ◽  
Proper Resolution ◽  
Tablet Dosage ◽  
Hptlc Method

Dolutegravir (DTG) is a second-generation integrase strand transfer inhibitor (INSTI), antiretroviral drug. RP-HPLC and HPTLC methods have been developed and validated for DTG in bulk and tablet dosage form. In HPLC method, analysis was carried out on C-18 column using a mixture of acetonitrile: phosphate buffer (pH 7.0) in the ratio of (90:10 V/V) as mobile phase at the flow rate 1 mL/min at 261 nm. The method was found to be linear in the concentration range 10-70 μg/mL. Peak for DTG was observed at 2.8 ± 0.1 minutes. For HPTLC method proper resolution was achieved with toluene: methanol: formic acid 7:3:0.1(V/V/V) as the mobile phase at 334 nm. HPTLC method was found to be linear in concentration range of 200-600 ng/band. Rf value of DTG was found to be 0.496 ± 0.0055. Developed methods were validated as per ICH guidelines Q2(R1) and were found to be accurate, precise, simple and robust.

scholarly journals A New Stability Indicating RP-HPLC Method for Determination of Chlorthalidone, Telmisartan and Cilnidipine in Bulk and Tablet Dosage Form

2020 ◽  
Vol 13 (1) ◽  
pp. 44-51
Author(s):  
S.Afreen Sultana ◽  
Patta. Salomi ◽  
T. VimalakKannan ◽  
K.Ravindra Reddy
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Potassium Dihydrogen ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Tablet Dosage

In present study, accurate, precise, rapid and sensitive stability indicting HPLC-UV method has been established for quantification of Telmisartan, Cilnidipine and Chlorthalidone simultaneously in Tablet and bulk. Telmisartan, Cilnidipine and Chlorthalidone were resoluted on Sunsil C18 column (4.6mmx250mm; 5μm) using mobile phase containing Acetonitrile and Potassium dihydrogen phosphate in 50:50(v/v) ratio with flow rate of 1ml/min at 238 nm. Concentrations were linear over the range of 40-120 μg/ml for Telmisartan, 10-30 μg/ml for Cilnidipine and 6.25-18.75 μg/ml for Chlorthalidone. The percentage recovery was found to be 99.70-100.51% for Telmisartan, 98.41-100.49% for Cilnidipine and 99.34-100.48% for Chlorthalidone. % RSD for peak area was 0.069% for Telmisartan, 0.058% for Cilnidipine and 0.057% for Chlorthalidone shows that the proposed method is precise. Force-degradation studies have not shown any observable change in the results and hence the proposed method is stability indicating and hence the method is suitable for routine analysis of Telmisartan, Cilnidipine and Chlorthalidone in bulk and tablet dosage form.

scholarly journals DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR DETERMINATION OF ERDAFITINIB IN MARKETED FORMULATIONS

2020 ◽  
Vol 9 (3) ◽  
Author(s):  
M. Maithani ◽  
D. Dwivedi ◽  
D. Hatwal ◽  
P. Bansal
Keyword(s):  
Mobile Phase ◽  
Pharmaceutical Preparations ◽  
Hplc Method ◽  
Sodium Acetate Buffer ◽  
Rp Hplc ◽  
The Mean ◽  
Uv Visible ◽  
Development And Validation ◽  
Tablet Dosage

A simple and precise RP-HPLC method for the estimation of Erdafitinib in tablet dosage form was developed and validated. The chromatographic separation of the drug was done with a Hypersil™ ODS C18 Column (150 mm × 4.6 mm i.d., particle size 5 μ) using 20mM sodium acetate buffer (pH 4. ±0.02), methanol and acetonitrile (60:10:30 v/v/v) as a mobile phase. The instrument was set at flow rate of 1.0 mLmin-1 at ambient temperature and the wavelength of UV-visible detector at 310nm. The method showed excellent linearity over a range of 5-35 μgmL-1 for the drug. The correlation coefficient for Erdafitinib was noted to be 0.9999. The mean recovery values were found to be 99.77% and 100.88%. The results suggest that the proposed method could be suitable for quantitative determination of Erdafitinib in pharmaceutical preparations and also for quality control in bulk manufacturing. The F-test and t-test at 95% confidence level were applied on data for statistical analysis.

A comparative technique using as Joint studying to prove structure and determination the Quantitative estimation of organic compound (Irbesartan) as drug in multicomponent tablet form

2019 ◽  
Vol 9 (o3) ◽  
Author(s):  
Imad Tarek Hanoon ◽  
Abed Mohammed Daheir AL-Joubory 2 ◽  
Marwa Mohamed Saied 3
Keyword(s):  
Mobile Phase ◽  
Chemical Structure ◽  
Quantitative Estimation ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Tablet Form ◽  
Rp Hplc ◽  
Percent Recovery

A simple , specific, accurate and precise RP-HPLC method was developed for determination of Irbesartan (IRB) in pharmaceutical dosage forms in tablets products and sachet using symmetry (L 1 ) column at 30°C . The signal was detected at 225 nm. A mobile phase dissolve 0.5 g of buffer potassium phosphate in 100 ml distilled water and adjust pH 2.7 , methanol and acetonitrile at ratio (40 :30 :30 ) . and flow rate 1.2ml/min -1 at pH=7.2 a mobile phase The percent recovery was detected 101 % and the linearity of concentration was 10-50 µg.ml -1 and supported this method by using (FT.I.R.) spectrum method for organic spectrophotometer to prove the chemical structure of this drug and some physical properties . we are obtained the result is identical of other literature . The proposed method was applied successfully for determination of the IRB in tablets products.

scholarly journals Box-Behnken Assisted Validation and Optimization of an RP-HPLC Method for Simultaneous Determination of Domperidone and Lansoprazole

Separations ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. 5
Author(s):  
Mohd Afzal ◽  
Mohd. Muddassir ◽  
Abdullah Alarifi ◽  
Mohammed Tahir Ansari
Keyword(s):  
Flow Rate ◽  
Mobile Phase ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Box Behnken Design ◽  
Rp Hplc ◽  
System Suitability ◽  
Method Optimization ◽  
Key Variables

A highly specific, accurate, and simple RP-HPLC technique was developed for the real-time quantification of domperidone (DOMP) and lansoprazole (LANS) in commercial formulations. Chromatographic studies were performed using a Luna C8(2), 5 μm, 100Å, column (250 × 4.6 mm, Phenomenex) with a mobile phase composed of acetonitrile/2 mM ammonium acetate (51:49 v/v), pH 6.7. The flow rate was 1 mL·min−1 with UV detection at 289 nm. Linearity was observed within the range of 4–36 µg·mL−1 for domperidone and 2–18 µg·mL−1 for lansoprazole. Method optimization was achieved using Box-Behnken design software, in which three key variables were examined, namely, the flow rate (A), the composition of the mobile phase (B), and the pH (C). The retention time (Y1 and Y3) and the peak area (Y2 and Y4) were taken as the response parameters. We observed that slight alterations in the mobile phase and the flow rate influenced the outcome, whereas the pH exerted no effect. Method validation featured various ICH parameters including linearity, limit of detection (LOD), accuracy, precision, ruggedness, robustness, stability, and system suitability. This method is potentially useful for the analysis of commercial formulations and laboratory preparations.

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