scholarly journals A Validated Stability Indicating RP-HPLC Method for the Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Pharmaceutical Dosage Form

2016 ◽  
Vol 54 (5) ◽  
pp. 759-764 ◽  
Author(s):  
Chinnalalaiah Runja ◽  
Pigili Ravi Kumar ◽  
Srinivasa Rao Avanapu
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Dosage Form ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc

scholarly journals Stability Indicating RP-HPLC Method For Determination Of Ketoconazole In Bulk Drug And In Tablet Dosage Form

2021 ◽  
Vol 001 (02) ◽  
Author(s):  
Shalin Parikh ◽  
Jayant Dave ◽  
Jayendrakumar Patel
Keyword(s):  
Dosage Form ◽  
Linear Regression Analysis ◽  
Hplc Method ◽  
Stress Conditions ◽  
Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Bulk Drug

A simple, precise, accurate and sensitive isocratic stability indicating RP-HPLC method has been developed and validated for determination of Ketoconazole in bulk drug and pharmaceutical dosage form. Isocratic RP-HPLC separation was achieved on Agilent C8 (150 mm ?4.6 mm, 5 µm particle size) with the mobile phase 0.3 % Triaethylamine in 20 mM potassium dihydrogen phosphate buffer pH adjusted to 4.0: Acetonitrile (68:32 % v/v) at a flow rate 1.0 ml/min. The retention time of Ketoconazole was 8.97 ± 0.50 min. The method was validated for specificity, linearity, precision, accuracy and robustness. The linear regression analysis data of calibration curve showed good linearity in concentration range 10-60 ?g/ml. The Intraday and Interday precision were 0.59-1.11 % and 0.26-1.73 % RSD respectively. The accuracy was found to be 98.11-99.26 %. The drug was subjected to the stress conditions like hydrolysis, oxidation, photolysis and dry heat. The proposed method is found to be specific with respect to degradation product formed after Acidic hydrolysis, Oxidation, Thermal and Photolytic degradation. The Ketoconazole was found to be stable under neutral hydrolytic, thermal and photolytic stress conditions. Acidic, thermal, photolytic stress conditions showed degradation. The proposed chromatographic method can be used for estimation of drug during stress testing & formal stability studies.

Development and Validation of a Stability Indicating RP-HPLC Method for the Determination of Imatinib Mesylate

2017 ◽  
Vol 8 (01) ◽  
Author(s):  
Y. Rajesh Babu ◽  
N. Appalaraju
Keyword(s):  
Imatinib Mesylate ◽  
Dosage Form ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Bulk Drug ◽  
The Stability

The aim of this paper was to develop and validate the stability indicating RP-HPLC method for the determination of Imatinib mesylate in bulk and pharmaceutical dosage forms. A simple, accurate, precise, sensitive and stability indicating RP-HPLC method has been developed for the determination of Imatinib mesylate in bulk drug and pharmaceutical dosage form, in which separations are done using develosil C18, 5μm, 150 × 4.6mm i.d. column at a flow rate of 1.0mL/min with an injection volume of 20μL. The beer’s law was obeyed over the concentration range of 5 - 35μg/mL. The correlation coefficient was found to be 0.996 and it showed good linearity, reproducibility, precision in this concentration range. The % recovery values were found to be within the limits, which showed that the method was accurate. The LOD and LOQ were calculated using statistical methods. The % RSD values were less than 2. The developed method was successfully applied for determination of Imatinib mesylate in pharmaceutical dosage form. The results obtained are in good agreement with those obtained by using the standard method.

New RP-HPLC Method Development and Validation for the Determination of Pazopanib Hydrochloride in Tablet Dosage Form

2017 ◽  
Vol 8 (1) ◽  
Author(s):  
Rajesh Babu Y. ◽  
Appala Raju N.
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Bulk Drug ◽  
The Stability

The aim of this paper was to develop and validate the stability indicating RP-HPLC method for the determination of Pazopanib hydrochloride in bulk and pharmaceutical dosage forms. A simple, accurate, precise, sensitive and stability indicating RP-HPLC method has been developed for the determination of Pazopanib hydrochloride in bulk drug and pharmaceutical dosage form, in which separations are done using develosil C18, 5μm, 150 × 4.6mm i.d. column at a flow rate of 1.0mL/min with an injection volume of 20μL. The beer’s law was obeyed over the concentration range of 5 - 35μg/mL. The correlation coefficient was found to be 0.996 and it showed good linearity, reproducibility, precision in this concentration range. The % recovery values were found to be within the limits, which showed that the method was accurate. The LOD and LOQ were calculated using statistical methods. The % RSD values were less than 2. The developed method was successfully applied for determination of Pazopanib hydrochloride in pharmaceutical dosage form. The results obtained are in good agreement with those obtained by using the standard method.

scholarly journals STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF PITOLISANT IN BULK AND PHARMACEUTICAL DOSAGE FORM

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
P. Venkateswara Rao ◽  
J. Leela Rani ◽  
M. Roja Kumari ◽  
G. Kalyani ◽  
G. Sirisha ◽  
...  
Keyword(s):  
Dosage Form ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc
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