scholarly journals Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Hydrochlorothiazide and Losartan Potassium in Tablet Dosage Form

2012 ◽  
Vol 10 (1) ◽  
pp. 35-42
Author(s):  
Md Arif Hossen ◽  
Md Ahsanul Haque ◽  
Irin Dewan ◽  
ANM Hamidul Kabir ◽  
Md Khalid Hossain ◽  
...  

In the present study, a simple, sensitive and specific liquid chromatography (RP-HPLC) method has been developed and validated for the quantification of hydrochlorothiazide and losartan potassium in tablet dosage form. A shim-pack CLC-ODS column (250 mm X 4.6 mm, 5μ and a mobile phase constituting 0.025 M phosphoric acid solution: acetonitrile (60:40 v/v, pH 3.0 adjusted with 80% phosphoric acid) were used. The flow rate was 1.5 ml/min and detection was carried by using ultraviolet (UV) detector at a wavelength of 254 nm. The retention times of hydrochlorothiazide and losartan potassium were 3.748 min and 8.790 min, respectively. The peaks of hydrochlorothiazide and losartan potassium were well separated (resolution 22.17). The calibration curves were linear over the concentration range of 80% to 120% (R2 > 0.999 for both the drugs). The proposed method is accurate with 100.165% recovery for hydrochlorothiazide and 100.422% recovery for losartan potassium and precise (% RSD < 0.5). The proposed method was successfully applied for the estimation of hydrochlorothiazide and losartan potassium in market products (three brands) and potency was found within limit. Therefore, this method can be a convenient and efficient option for the analysis of hydrochlorothiazide and losartan potassium in tablet dosage form. DOI: http://dx.doi.org/10.3329/dujps.v10i1.10013 DUJPS 2011; 10(1): 35-42

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 2435-2441
Author(s):  
Ashok B. Patel ◽  
Amitkumar J. Vyas ◽  
Shital Faldu ◽  
Arvind N Lumbhani ◽  
Nikunj J. Patel ◽  
...  

A novel, simple, specific, accurate & precise stability-indicating Gradient reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed for simultaneous estimation of Cilnidipine & Chlorthalidone in tablet dosage form, validated as per ICH guideline. The separation was achieved on Inertsil ODS column (250 mm x 4.6 mm, 5 μm) in a gradient mode.  The mobile phase consisted of Methanol, 0.025 M Potassium dihydrogen phosphate Buffer pH 5.5 adjusted by 10% v/v Ortho Phosphoric Acid (50:50 v/v) (Solution A) and Acetonitrile, 0.025 M Potassium dihydrogen phosphate Buffer pH 5.5 adjusted by 10%v/v Ortho Phosphoric Acid (75:25 v/v) (Solution B), gradient programming for 20 min at 1 ml/min rate of flow and response was detected at 225 nm. The retention time was found to be 3.580 min and 12.606 mins for Chlorthalidone and Cilnidipine, respectively. The method is validated according to ICH guideline, which includes linearity, specificity, accuracy, precision and robustness. Linearity was obtained over the concentration range of 10-60 μg/ml for Cilnidipine and 6.25-37.5 μg/ml for Chlorthalidone, had a regression coefficient (r2) almost 0.9966. The % Recovery was found to be 99.63-100.59 % and 100.24-100.51 % for Cilnidipine and Chlorthalidone, respectively. The method was found to be specific enough to separate all degradation products from the active compound. Drug samples were exposed to various stress conditions like photolysis, oxidation, heat conditions, and hydrolysis (acidic and alkaline), there was no interference of any degradants and excipient in the determination of drugs so that methods can be successfully applied for routine QC analysis.


Author(s):  
Gundapaneni Ravi Kumar ◽  
Rayala Rama Rao ◽  
Vadde Megha Vardhan ◽  
V. D. N. Kumr Abbaraju

Background: In the current study, asimple and specific stability indicating RP-HPLC method was developed and validated for the determination of Lamivudine and Raltegravir in bulk drug and it tablet dosage form using an UV-detector. Good separation was achieved by isocratic ally on a Zorbax SB-Phenyl (150 × 4.6 mm, 3.5 μ, 80 A°) column, using a mobile phase composition of buffer (0.1% v/v Phosporic acid in water): Acetonitrile (40:60 v/v) at a flow rate of 1.0 mL/min. The eluted analytes detected at 260 nm wavelength. Results: Lamivudine and Raltegravir were eluted at 3.1 and 5.4 min respectively with run time 7 min. Linearity in the method was measured in the concentration range of 30 – 70 μg/mL and 60 – 140 μg/mL for Lamivudine and Raltegravirrespectively. The percentage recoveries of Lamivudine and Raltegravirwere determined to be 100.30% and 100.53%, respectively. The validation of the developed method is carried as per USFDA and ICH guidelines, and the degradants were well resolved from Raltegravir and Lamivudine peaks. The developed RP-HPLC method was highly precise, specific, sensitive, and stability indicating. Conclusion: The results of the analysis prove that thedeveloped RP-HPLC method is simple, economical and widely acceptable, which can be used in routine quality control tests in the industry.


2012 ◽  
Vol 24 (1) ◽  
pp. 15-22 ◽  
Author(s):  
P. B. Deshpande ◽  
S. V. Gandhi ◽  
N. V. Gaikwad ◽  
K. S. Khandagle

2012 ◽  
Vol 2 (5) ◽  
Author(s):  
Kumaraswamy Gandla ◽  
JMR Kumar ◽  
JVLN Sheshagiri Rao ◽  
M Lakshmi Surekha

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (06) ◽  
pp. 51-61
Author(s):  
J. G Modi ◽  
◽  
J. K. Patel

A novel, simple, rapid, and highly selective stability indicating RP-HPLC method was developed and validated for simultaneous estimation of azilsartan medoxomil (AZL) and amlodipine besylate HCl (AMLO) in tablet dosage form having strength of 20 mg and 2.5 mg, respectively. The effective chromatographic separation was achieved on a Phenomenex luna ODS C18 (15 cm X 4.6 mm internal diameter, 3.5 μm Particle size) with a mobile phase composed of phosphate buffer (pH-2.5) adjusted with ortho phosphoric acid : acetonitrile in the ratio of 60:40 v/v. The mobile phase was pumped using an isocratic HPLC system at a flow rate of 0.7 mL/min with injection volume 20μl and quantification of the analytes was done at detection wavelength 254 nm. The retention times were found to be 5.918 min and 14.901 min for AMLO and AZL, respectively. The proposed HPLC method was validated with respect to linearity, ranges, precision, accuracy, specificity, robustness, LOD, and LOQ as per ICH Q2 (R1) guideline. Calibration plots were linear over the concentration range of 75-125 µg/mL and 600-1000 µg/mL with correlation coefficients 0.9966 and 0.9948 for AMLO and AZL, respectively. Forced degradation studies were performed using hydrolysis, oxidation, photolytic, and thermal degradation conditions with good resolution between the degradants and analytes. Degradation products resulting from the stress studies did not interfere with the detection of AMLO and AZL, thus the proposed method is sensitive and stability-indicating. The validated HPLC method was successfully applied to the analysis of AMLO and AZL in tablet dosage form.


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