Development and validation of a reversed-phase HPLC method for simultaneous estimation of ambroxol hydrochloride and azithromycin in tablet dosage form

2008 ◽  
Vol 48 (5) ◽  
pp. 1481-1484 ◽  
Author(s):  
K.A. Shaikh ◽  
S.D. Patil ◽  
A.B. Devkhile
2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Dipali Patel ◽  
Nishitkumar Patel ◽  
Reeta Vaishy ◽  
Viral Patel ◽  
Chiragsinh Solanki ◽  
...  

A simple, specific, precise, and accurate reversed-phase HPLC method was developed and validated for simultaneous estimation of aspirin and esomeprazole magnesium in tablet dosage forms. The separation was achieved by HyperChrom ODS-BP C18column (200 mm × 4.6 mm; 5.0 μm) using acetonitrile: methanol: 0.05 M phosphate buffer at pH 3 adjusted with orthophosphoric acid (25 : 25 : 50, v/v) as eluent, at a flow rate of 1 mL/min. Detection was carried out at wavelength 230 nm. The retention times of aspirin and esomeprazole magnesium were 4.29 min and 6.09 min, respectively. The linearity was established over the concentration ranges of 10–70 μg/mL and 10–30 μg/mL with correlation coefficients (r2) 0.9986 and 0.9973 for aspirin and esomeprazole magnesium, respectively. The mean recoveries were found to be in the ranges of 99.80–100.57% and 99.70–100.83% for aspirin and esomeprazole magnesium, respectively. The proposed method has been validated as per ICH guidelines and successfully applied to the estimation of aspirin and esomeprazole magnesium in their combined tablet dosage form.


2019 ◽  
Vol 6 (2) ◽  
pp. 95
Author(s):  
Fikri Alatas ◽  
Hernandi Sujono ◽  
Woro Artati Sucipto

<p align="center"><strong>Abstrak</strong><strong></strong></p><p align="center"><strong> </strong></p><p>Metode kromatografi cair kinerja tinggi (KCKT) dengan detektor ultra lembayung telah dikembangkan dan divalidasi untuk estimasi kadar secara simultan campuran piridoksin hidroklorida (PH) dan piratiazin teoklat (PT)dalam sediaan tablet antiemetik. Proses pemisahan terjadi dalam kolom Inertsil® ODS-3 pada panjang gelombang 280 nm dengan laju alir 1,0 mL/menit. Fase gerak yang optimal untuk pemisahan adalah campuran methanol-asam asetat 1% (20:80) dengan waktu retensi PH dan PT berturut-turut adalah 1,2 dan 9,8 menit. Perolehan kembali PH dan PT berturut-turut adalah 100,13 dan 99,78 %. Batas deteksi untuk PH dan PT berturut-turut adalah 0,21 dan 0,22 µg/mL, sedangkan batas kuantisasinya berturut-turut adalah 0,70 dan  0,72 µg/mL. Metode ini dapat diterapkan sebagai metode untuk estimasi kadar campuran piridoksin hidroklorida dan piratiazin teoklat dalam bentuk sediaan tablet secara simultan.</p><p> </p><p><strong>Kata kunci:</strong> Piridoksin hidroklorida, piratiazin teoklat, KCKT, tablet</p><p> </p><p align="center"><strong><em>Development and validation of high performance liquid chromatography (HPLC) method for simultaneous estimation of antiemetic pyridoxyne hydrochloride and pyrathiazine theoclate in tablet dosage form</em></strong></p><p> </p><p align="center"><strong><em>Abstract</em></strong><strong><em></em></strong></p><p><em> </em></p><p><em>The high performance liquid chromatography (HPLC) method with an ultra violet detector has been developed and validated for simultaneous estimation of pyridoxine hydrochloride (PH) and pyrathiazine theoclate (PT) in antiemetic tablet preparations. The separation process occurs in the Inertsil® ODS-3 column at a wavelength of 280 nm with a flow rate of 1.0 mL /min. The optimal mobile phase for separation is a mixture of methanol-acetic acid 1% (20:80) with the retention times of PH and PT 1.2 and 9.8 minutes respectively. The recoveries of PH and PT were 100.13 and 99.78%, respectively. The detection limits for PH and PT were 0.21 and 0.22 µg / mL respectively, while the quantisation limits were 0.70 and 0.72 µg / mL, respectively. This method can be applied as a method for simultaneous estimating the levels of pyridoxine hydrochloride and pyrathiazine theoclate in tablet dosage form.</em><em></em></p><p><em> </em></p><p><strong><em>Keywords:</em></strong><em> Pyridoxine hydrochloride, pyrathiazine theoclate, HPLC, tablet</em></p>


INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (08) ◽  
pp. 12-16
Author(s):  
S Vidyadhara ◽  
◽  
L. S Reddyvalam ◽  
T. Koduri ◽  
P. K. Borra ◽  
...  

A simple, accurate, precise high-performance liquid chromatographic (HPLC) method has been developed and validated for the simultaneous determination of abacavir sulphate (ABA) and lamivudine (LAM) in combined dosage form. Separation was performed on a C18 column [Agilent ODS UG 5 column, 250 mm x 4.5 mm], with methanol: water (50:50 V/V) isocratic elution using a flow rate of 1mL/min. Good sensitivity was observed with UV detection at 277 nm. After method development, the interference of other active compounds and excipients, repeatability and linearity, were investigated. Retention times of LAM and ABA were found to be 3.3 and 6.3 min, respectively. The method was validated over the range from 2.5-12.5 μg/mL for LAM and 5-25 μg/mL for ABA with correlation coefficients of 0.9997 and 0.9996, respectively. This method was shown to be accurate, robust, selective, linear, and repeatable and can be successfully employed in routine quality control for the simultaneous analysis of ABA and LAM in tablets.


Author(s):  
D. Chinababu

Aim: The objective of the study was simplest, accurate, precise and robust reversed phase high performance liquid chromatographic (RP-HPLC) method was developed for the estimation of Velpatasvir (VEL) and Sofosbuvir (SOF) in the bulk and its tablet dosage form. Study Design: The Quantitative and Qualitative estimation and designed forced degradation study of Velpatasvir & Sofosbuvir by RP-HPLC. Place and Duration of Study: The study was carried at Santhiram College of Pharmacy and time taken 4 months. Method: The method was attained by used Waters( 5µm, C18 250 x 4.6 mm) column with mobile phase consists of  0.5 mM disodium hydrogen phosphate buffer pH adjusted to 6.5, with Orthophosphoric acid and Methanol in the ratio of 78:22 v/v, a flow rate of 1.0 mL/min and ultraviolet detection at 285 nm. Results: The method was validated as per ICH guidelines with different parameters, the mean retention times of VEL and SOF were found to be 2.8 & 4.7 min respectively. The resolution between VEL and SOF was found to be 10.66. The Correlation coefficients for calibration curves within the detection range of 32.5 - 97.5 and 125 - 375 µg/mL were 0.999 for VEL and SOF respectively. The LOD and LOQ for VEL and SOF were found to be 0.0068-0.029 µg/mL and 0.104-0.342 µg/mL respectively. Conclusion: The results were indicated that the developed method was used for the routine analysis of VEL & SOF combined form in bulk and its commercial formulation. To the best of our knowledge, there was no method of RP-HPLC for the determination of VEL alone or in combination with SOF molecule.


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