scholarly journals Validated stability indicating RP-HPLC method for the determination of phenazone and lidocaine hydrochloride in bulk and dosage form

2021 ◽  
Vol 7 (4) ◽  
pp. 172-178
Author(s):  
Charushila J Bhangale ◽  
Shivanand Hiremath
Keyword(s):  
Dosage Form ◽  
Hplc Method ◽  
Lidocaine Hydrochloride ◽  
Stability Indicating ◽  
Rp Hplc

scholarly journals Validation of a Stability-Indicating RP-HPLC Method for the Determination of Entecavir in Tablet Dosage Form

2010 ◽  
Vol 93 (2) ◽  
pp. 523-530 ◽  
Author(s):  
Sérgio Luiz Dalmora ◽  
Maximiliano da Silva Sangoi ◽  
Daniele Rubert Nogueira ◽  
Lucélia Magalhães da Silva
Keyword(s):  
Dosage Form ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Forced Degradation ◽  
Photodiode Array Detection ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Tablet Dosage

Abstract An RP-HPLC method was validated for the determination of entecavir in tablet dosage form. The HPLC method was carried out on a Gemini C18 column (150 4.6 mm id) maintained at 30C. The mobile phase consisted of acetonitrilewater (95 + 5, v/v)/potassium phosphate buffer (0.01 M, pH 4; 9 + 91, v/v) pumped at a flow rate of 1.0 mL/min. Photodiode array detection was at 253 nm. The chromatographic separation was obtained with a retention time of 4.18 min, and the method was linear in the range of 0.5200 g/mL (r2 0.9998). The specificity and stability-indicating capability of the method was proven through forced degradation studies, which also showed that there was no interference of the excipients and an increase of the cytotoxicity only by the basic condition. The accuracy was 101.19, with bias lower than 1.81. The LOD and LOQ were 0.39 and 0.5 g/mL, respectively. Method validation demonstrated acceptable results for precision and robustness. The proposed method was applied for the analysis of tablet formulations, to improve QC and assure therapeutic efficacy.

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.

CHEMOMETRICS ASSISTED STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ACETYL CYSTEINE AND AMBROXOL HYDROCHLORIDE IN BULK AND DOSAGE FORM

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (03) ◽  
pp. 46-53
Author(s):  
H. Potluri ◽  
Keyword(s):  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Tablet Formulations ◽  
Acetyl Cysteine ◽  
Ambroxol Hydrochloride ◽  
Full Factorial

A simple and precise stability indicating RP-HPLC method was developed for the simultaneous estimation of acetyl cysteine and ambroxol hydrochloride in bulk and dosage form. Experimental design based evaluation using a 23 full factorial design was applied to evaluate coefficient, ANOVA for the establishment of robustness nature of the method. Kromosil (250 mm x 4.6 mm, 5 μ) C18 column at 274 nm of UV detection was used. A composition of 0.1 % ortho phosphoric acid and acetonitrile in the ratio of 28:72 (V:V) was used as the mobile phase with a flow rate of 1.0 mL min-1. Linearity was established over the concentration range of 50-300 μg. mL-1 for acetyl cysteine and 7.5-45 μg mL-1 for ambroxol hydrochloride. The proposed method was validated and was successfully utilized for the quantitative analysis of tablet formulations containing acetyl cysteine and ambroxol hydrochloride.

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.

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