scholarly journals Stability indicating method development and validation for the determination of haloperidol and benzhexol by RP-HPLC

2019 ◽  
Vol 1 (2) ◽  
pp. 52-58 ◽  
Author(s):  
M. Syamala ◽  
S Angalaparameswari ◽  
T. VimalakKannan ◽  
C. Sumanjali ◽  
T. Jyotshna
Keyword(s):  
Method Development ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Quality Control Test

A simple, Accurate, precise method was developed for the simultaneous estimation of the Haloperidol and Benzhexol in Tablet dosage form. The chromatogram was run through Kromasil (250mm 4.6mm, 5µ). Mobile phase containing Buffer and Acetonitrile and methanol in the ratio of 48:52 was pumped through column at a flow rate of 1.0 ml/min. The temperature was maintained at 30°C. The optimized wavelength for Haloperidol and Benzhexol was 220nm. The retention time of Haloperidol and Benzhexol were found to be 2.415 min and 2.820min. %RSD of the Haloperidol and Benzhexol were and found to be 0.6 and 0.2 respectively. %Recover was Obtained as 98.92% and 99.60% for Haloperidol and Benzhexol. LOD, LOQ values were obtained from regression equations of Haloperidol and Benzhexol were 0.42ppm, 1.27ppm and 0.04ppm, 0.14ppm respectively. Regression equation of Haloperidol is y = 24009x + 38704, and of Benzhexol is y = 40558x + 2880. Retention times are decreased and that 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 STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LEDIPASVIR AND SOFOSBUVIR IN BULK DRUG BY USING RP-HPLC

2020 ◽  
pp. 307-318
Author(s):  
RowthulaPrasanna Surya Bhavani RowthulaPrasanna Surya Bhavani ◽  
M.Sandhya Maduri M.Sandhya Maduri
Keyword(s):  
Method Development ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Bulk Drug ◽  
Development And Validation ◽  
Tablet Dosage

A new, simple, precise, accurate, and reproducible RP-HPLC for stability-indicating method development and validation of Ledipasvir and Sofosbuvir in bulk form. Separation ofLedipasvir and Sofosbuvir was successfully achieved Dona Zorbax C8, 250 X4.6mm, 5µm or equivalent in an isocratic mode utilizing 0.1% OPA: Methanol (45:55) at a flow rate of 1.0mL/min and the eluate was monitored at 238nm, with a retention time of 3.303 and 7.303minutes for Ledipasvir and Sofosbuvir respectively. The method was validated and their response was found to be linear in the drug concentration range of 45µg/ml to135 µg/ml for Ledipasvirand 200µg/ml to 600 µg/ml for and Sofosbuvir. The values of the correlation coefficient were found to 0.999 for Ledipasvirand 1 for Sofosbuvir respectively. The LOQ for Ledipasvirwere found to be  0.695 respectively. The LOQ for Sofosbuvir was found to be 2.2063 respectively. This method was found to be a good percentage recovery for Ledipasvir and Sofosbuvirwere found to be 100 and 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows a good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from the excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precession, Specificity, and Robustness.

scholarly journals Analytical Method Development and Validation of Rp-Hplc Method for Simultaneous Estimation of Pyridoxamine Dihydrochloride and Acetylcysteine in Tablet Dosage Form.

2021 ◽  
Vol 23 (06) ◽  
pp. 992-1000
Author(s):  
Sneha S. Ghule ◽  
◽  
Ashpak M. Tamboli ◽  
Snehal D. Patil ◽  
◽  
...  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
System Suitability ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Pyridoxamine dihydrochloride and Acetylcysteine in the marketed formulation is developed. Chromatography carried out at 30oc temperature on Agilent Zorbax Bonus-RP (250 x 4.6 mm, 5 µ) coloum. Coloum using a mobile phase 0.1% trifluroacetic acid in water: acetonitrile (80:20v/v) with flow rate 1ml/min (DAD scan at 210nm). Validation parameters such as system suitability, linearity, precision, accuracy are considered as reported International Conference on Harmonization guidelines. The retention times for Pyridoxamine dihydrochloride and Acetylcysteine are 2 min and 3.4 min. The linearity range for Pyridoxamine dihydrochloride and Acetylcysteine is 30-70 µg/ml and 180-420 µg/ml. The %RSD for accuracy was found to be less than 2%. Hence the proposed method was found to be accurate, precise, reproducible, and specific and can be used for simultaneous analysis of these drugs in tablet formulation.

Method Development and Validation for Estimation of Istradefylline in Tablet Dosage form by RP-HPLC

2021 ◽  
pp. 4767-4772
Author(s):  
Krishna Kishore Adireddy ◽  
Srinivasa Rao Baratam ◽  
Nagarjuna Hari Pratap S
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Solution Stability ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of Istradefylline in table dosage form. Chromatographic analysis of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of 0.1 % orthophosphoric acid and acetonitrile in the ratio of 30: 70 v/v. The method showed a good linear response in the concentration range of 10-90 μg/ml with correlation coefficient of 0.9993. The flow rate was maintained at 1.0 ml/min and detection was carried out at 246 nm. The retention time was 3.125 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of istradefylline in tablet formulation.

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LINAGLIPTIN AND EMPAGLIFLOZIN

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (05) ◽  
pp. 68-71
Author(s):  
A Lakshmana Rao ◽  
◽  
T. Prasanthi ◽  
E. L Anusha
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

A simple, accurate and precise RP-HPLC method was developed for the simultaneous estimation of the linagliptin and empagliflozin in tablet dosage form. Chromatogram was run through Kromasil 250 x 4.6 mM, 5mM column, mobile phase containing 0.1% o-phosphoric acid buffer and acetonitrile in the ratio of 60:40%v/v was pumped through column at a flow rate of 1 mL/min. The optimized wavelength was 230 nm. Retention times of linagliptin and empagliflozin were found to be 2.759 min and 2.139 min. %RSD of the Linagliptin and Empagliflozin were found to be 0.5 and 0.6 respectively. Percentage assay was obtained as 99.91% and 100.15% for linagliptin and empagliflozin, respectively. LOD, LOQ values obtained for linagliptin and empagliflozin were 0.23 μg/ml and 0.44 μg/mL and 0.70 μg/mL and 1.34 μg/mL, respectively. Thus, the current study showed that the developed RP-HPLC method is sensitive and selective for the estimation of linagliptin and empagliflozin in combined dosage form.

RP-HPLC Method Development and Validation for the simultaneous estimation of Atazanavir sulphate and Ritonavir in bulk and tablet dosage form

2014 ◽  
Vol 1 (3) ◽  
pp. 50
Author(s):  
Ananda Thangadurai Subramaniam ◽  
Jambulingam Munusamy ◽  
Saravanakumar Sengodan ◽  
Kamalakannan Danapal ◽  
Haritha D Siva Ganga Lakshmi ◽  
...  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage
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