A NOVEL STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF NEBIVOLOL AND INDAPAMIDE IN BULK AND PHARMACEUTICAL FORMULATIONS

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (09) ◽  
pp. 67-73
Author(s):  
B. Venkateswara Rao ◽  
◽  
S. Vidyadhara ◽  
A. Ramu ◽  
N. Sai Prudhvi ◽  
...  
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Liquid Chromatography Method ◽  
Hplc Method Development ◽  
Liquid Chromatographic

A simple, precise, accurate, reproducible and economical stability- indicating reverse phase liquid chromatography method was developed and validated for the quantitative simultaneous estimation of nebivolol and indapamide in bulk and marketed formulations. Estimation of drugs in this combination was done with a C18 column [Kromasil column. 250mm × 4.5 mm] using mobile phase of composition acetonitrile and phosphate buffer (60:40 V/V, pH 3). The flow rate was 0.8 ml/min and the effluents were monitored at 226nm. The retention time of nebivolol and indapamide were 2.9 min and 4.2 min, respectively. The method was found to be linear over a range of 10-50 μg/mL for nebivolol and 2-10 μg/mL for indapamide. The established method proved as reproducible one with a % RSD value of less than 2 and having the robustness and accuracy within the specified limits. Assay of marketed formulation was determined and found to be 99.08% and 99.87% for nebivolol and indapamide, respectively. The stressed samples were analyzed and this proposed method was found to be specific and stability indicating as no interfering peaks of degradation compounds and excipients were noticed. The method was validated according to the guidelines of International Conference on Harmonization (ICH) and was successfully employed in the estimation of commercial formulations. This liquid chromatographic method can be applied for the qualitative and quantitative determination of selected drugs by the modern chemist.

A NOVEL STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF VALSARTAN AND HYDROCHLOROTHIAZIDE IN BULK AND PHARMACEUTICAL FORMULATIONS

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (08) ◽  
pp. 54-61
Author(s):  
B. Venkateswara Rao ◽  
◽  
S. Vidyadhara ◽  
V. Basaveswara Rao
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Liquid Chromatography Method ◽  
Hplc Method Development ◽  
Development And Validation

The prime aim of the present investigation was to develop and validate a novel, precise, accurate, specific, rapid and economical stability- indicating isocratic reverse phase liquid chromatography method for the quantitative simultaneous estimation of valsartan and hydrochlorothiazide in bulk and marketed formulations. Estimation of drugs in this combination was achieved with a C18 column [Kromasil 100-5 C18 column, P134 250 × 4.6 mm] kept at ambient temperature, isocratic mode using mobile phase of composition acetonitrile and phosphate buffer (40:60 V/V, pH 4). The flow rate was 0.8 ml/min and the effluents were monitored at 235 nm, using variable wavelength UV detector. The retention time of valsartan and hydrochlorothiazide were 2.65 min and 3.97 min, respectively. Validation of the method was done according to the ICH guidelines for different analytical parameters. The method was found to be linear over a range of 50-250 μg/mL for valsartan and hydrochlorothiazide. The established method was as reproducible with a %RSD value of less than 2 and having robustness and accuracy within the specified limits. Assay of marketed formulation was determined and was 99.04% and 99.8% respectively. The stressed samples were analyzed. The proposed method was found to be specific and stability indicating as no interfering peaks of degradation compounds and excipients were noticed. The proposed method can be successfully employed in the estimation of commercial formulations.

STABILITY INDICATING RP - HPLC METHOD DEVELOPMENT FOR THE SIMULTANEOUS ESTIMATION OF LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE AND EFAVIRENZ IN BULK AND PHARMACEUTICAL FORMULATION

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (11) ◽  
pp. 57-63
Author(s):  
V. Suryadevara ◽  
◽  
R. L Sasidhar ◽  
B. Venkateswara Rao ◽  
T. N. V. Ganesh Kumar ◽  
...  
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
High Performance ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Hplc Method Development ◽  
Liquid Chromatographic

A simple, accurate reverse phase high performance liquid chromatographic method has been developed for the simultaneous estimation of lamivudine, tenofovir disoproxil fumarate and efavirenz in bulk and pharmaceutical formulations. The analytical method development was carried on Agilent make HPLC instrument using RP - C18 column. The mobile phase employed for the estimation is phosphate Buffer pH 4.0 :acetonitrile adjusted to pH 4.0 with glacial acetic acid which was pumped at a flow rate of 1.0 mL min-1 in the ratio of 42:58 v/v. the eluents were monitored at 260 nm. Linearity was obtained in the concentration range of 20-100 μg/mL of lamivudine, tenofovir disoproxil fumarate and 100-500 μg/mL efavirenz. Degradation studies shows that all the three drugs were not degraded under acidic, alkaline, thermal and photolytic conditions.The method was statistically validated and RSD was found to be within limits. Due to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method can be applied for determining lamivudine, tenofovir disoproxil fumarate and efavirenz in bulk and in pharmaceutical dosage form.

scholarly journals Stability indicating RP-HPLC method development and validation for the simultaneous estimation of ceftriaxone and tazobactum in sterile powder for injection

2019 ◽  
Vol 1 (2) ◽  
pp. 40-43
Author(s):  
T. Vimalakkannan ◽  
P. Shaik Parveen ◽  
Salomi ◽  
K. Ravindra Reddy
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Accurate Method ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation

A simple, rapid, precise and accurate method is developed for the quantitative simultaneous determination of ceftriaxone and tazobactum in bulk and pharmaceutical formulations. Separation of ceftriaxone and tazobactum was successfully achieved by using Inertsil C18 ODS column 250X4.6mm, 5µm in an isocratic mode using water and acetonitrile (80:20) at a flow rate of 1.0 ml/min and was monitored at 254 nm with a retention time of 3.049 minutes and 4.317 minutes for ceftriaxone and tazobactum respectively. The method was validated and the response was found to be linear in the drug concentration range of 20µg/ml to 80 µg/ml for ceftriaxone and 5 µg/ml to 35 µg/ml for tazobactum. The values of the correlation coefficient were found to be 0.999 for ceftriaxone and 0.999 for tazobactum respectively. The LOD and LOQ for ceftriaxone were found to be 0.021 and 0.064 respectively. The LOD and LOQ for tazobactum were found to be 0.030 and 0.091 respectively. The percentage recovery for ceftriaxone and tazobactum were found to be 98-102% respectively which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness.  Stability of the drugs was determined by using acid/base, thermal, oxidative stress testing.

RP-HPLC METHOD DEVELOPMENT FOR THE ASSAY OF AMPHOTERICIN B

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (02) ◽  
pp. 16-20
Author(s):  
L Mohankrishna ◽  
◽  
P. J. Reddy ◽  
B. P Reddy. ◽  
P. Navya
Keyword(s):  
Amphotericin B ◽  
Mobile Phase ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Phase Combination ◽  
Hplc Method Development

A sensitive and precise HPLC procedure has been developed for the assay of amphotericin B in bulk samples and pharmaceutical formulations by using a C18 column [Kromosil, C18, (5 µm, 4.6mm x 250 mm; Make. Waters)], and mobile phase combination is 1% formic acid in water and acetonitrile in ratio of 45:55 V/V. The procedure has been validated as per the ICH guidelines. The λmax of detection was fixed at 407 nm, so that there was less interference from mobile phase with highest sensitivity according to UV analysis. Calibration plots were linear in the range of 10-100 µg/mL and the LOD and LOQ were 0.02 µg/mL and 0.06 µg/mL respectively. The high recovery and low relative standard deviation confirm the suitability of the method for routine quality control determination of amphotericin B in different formulations.

scholarly journals VALIDATION OF STABILITY INDICATING ULTRA-FAST LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF ATENOLOL and NIFEDIPINE IN BOTH BULK AND PHARMACEUTICAL DOSAGE FORMS

2018 ◽  
Vol 10 (3) ◽  
pp. 27
Author(s):  
Arunsrikar M. ◽  
R. S. Chandan ◽  
Anand Kumar Tengli ◽  
Venkata Sairam K.
Keyword(s):  
Simultaneous Estimation ◽  
Combination Drug ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Ich Guidelines ◽  
Acid And Base ◽  
Liquid Chromatography Method ◽  
Fast Liquid Chromatography ◽  
Liquid Chromatographic

Objective: The study depicts improvement of ensuing validation of a stability indicating technique for the simultaneous estimation of Atenolol and Nifedipine using Ultra-fast liquid chromatographic method (UFLC).Methods: The analysis is performed on Phenomenex Kinetex C18, (150 × 4.6 mm, 5μm) column using methanol and 0.1%ortho-phosphoric acids (75:25 v/v) as mobile phase with a flow rate of 1.3 ml/min. The eluents were checked with PDA detector at 237 nm.Results: In this optimized conditions Atenolol and Nifedipine elutes at a retention time of 2.79 and 4.50 min respectively individually the considered optimized condition is having linearity in the range from 10 to 50µg/ml of Atenolol and 4-20µg/ml of Nifedipine. The method was validated by following the ICH guidelines and their combination drug yield was exposed to acid and base stress, thermal stress, photolytic stress, hydrolytic stress, and oxidative stress conditions. All samples were studied by the given optimized method. In this Calibration curves were linear over studies ranges with correlation coefficient found between the ranges of 0.99 to 1.00.Conclusion: The proposed method was found to be accurate, precise, and specific and suitable for determination of both the drugs.

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