DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATE IN PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (01) ◽  
pp. 35-40
Author(s):  
A. S. Bagde ◽  
V. V. Khanvilkar ◽  

The present work describes a validated reverse phase high performance liquid chromatography (RPHPLC) method for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate in pharmaceutical dosage from. The drugs were resolved using Hemochrom Intsil C18-5U column (250×4.6) mm in isocratic mode with mobile phase methanol: water (0.08% diethylamine, 0.02% of glacial acetic acid and pH 4.4 adjusted with orthophosphoric acid) in the ratio of 70:30 V/V at a flow rate of 1.0 mL/min. Retention time of dextromethorphan hydrobromide and quinidine sulphate were 4.9±0.2 and 3.6±0.2, respectively, at 292nm. The above mentioned method was validated as per International Conference on Harmonization (ICH) guidelines. Linear responses were obtained in concentration ranges of 5-35 μg/mL for dextromethorphan hydrobromide and 4-16 μg/mL for quinidine sulphate, with correlation coefficient (r2) of 0.999 for both the drugs. A simple, selective, accurate, precise, robust and reliable RP-HPLC method thus developed and validated for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate.

2013 ◽  
Vol 2013 ◽  
pp. 1-7
Author(s):  
Neha Singhal ◽  
Kalpesh Gaur ◽  
Anoop Singh ◽  
Karni Singh Sekhawat

The present study described a new, simple, accurate, and precise high performance liquid chromatography method for the simultaneous determination of Ambroxol and Doxofylline in combined tablet dosage form. The chromatographic method was standardized using a BDS hypersil C18, 250 mm × 4.6 mm, 5 μ (particle size), Thermo scientific from Germany with isocratic conditions, and mobile phase containing potassium dihydrogen orthophosphate buffer-pH 4.5 (0.05 M KH2PO4): acetonitrile (60 : 40) at flow rate of 1 ml/min using UV detection at 254 nm. The retention times of Ambroxol and Doxofylline were 3.510 min and 7.247 min, respectively. The method was linear over the concentration range for Ambroxol 3.75–11.25 μg/mL and for Doxofylline 50-150 μg/mL. The recovery of Ambroxol and Doxofylline was found to be in the range of 99.42–101.18% and 99.37–100.28%, respectively. The validation of method was carried out using ICH guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form.


Author(s):  
MEGHA PATEL ◽  
PARESH PATEL ◽  
DHARA PATEL

Objective: A simple, rapid, accurate, precise, specific, and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated for simultaneous estimation of olanzapine (OLZ) and aripiprazole (APR) in synthetic mixtures. Methods: The stationary phase used for chromatographic separation was Phenomenex C18 column (250 mm × 4.6 mm i.d, particle size 5 μm) and mobile phase used for separation was methanol: Phosphate buffer (pH 3) taken in ratio of 75:25 %v/v. The flow rate was used 1.0 ml/min at room temperature and drugs detected at 240 nm with injection volume 20 μL. Results: The retention time for OLZ and APR was found to be 4.231 and 6.523 min, respectively. The linearity was performed using a concentration range of 0.5–3.0 for both drugs. The correlation coefficient was found to be 0.999 for OLZ and APR. The % purity of both the drug was found to be 98–102%. The proposed RP-HPLC method has been validated, according to International council on harmonization Q2 (B) guidelines. Conclusion: There was no interference of any diluents and excipients in the determination of drugs from synthetic mixture. Hence, the developed method can be used for routine quality control analysis.


Author(s):  
Anjoo Kamboj ◽  
Manisha Bhatti ◽  
Pooja Atri

ABSTRACTObjective: Xanthium strumarium is a cocklebur or burweed belonging to family Asteraceae and commonly found as a weed, is widely distributed inNorth America, Brazil, China, Malasia, and hotter part of India. The herb is traditionally used mostly in treating several ailments. The present studydeals with development and validation of a reliable reverse phase high-performance liquid chromatography (RP-HPLC) method for the simultaneousestimation of Stigmasterol and β-sitosterol in the various extracts of the plant.Methods: The proposed method utilizes a Qualisil Gold C18 column (250×4.6 mm), 5 µm particle size, under isocratic elution conditions with themixture of acetonitrile:ethanol:water (85:14:1 v/v/v) at 25° as a mobile phase. An effluent flow rate of 1 ml/minute and ultraviolet detection at202 nm was used for the analysis of Stigmasterol and β-sitosterol.Results: The described method was linear in the range of range of 100-500 µg/ml and 10-500 µg/ml for stigmasterol and β-sitosterol respectively,with excellent correlation coefficients. The precision, robustness, and ruggedness values were also within the prescribed limits (<2%). The recoveryvalues were within the range, which indicates that the accuracy of the analysis was good and that the interference of the matrix with the recovery ofphytosterols was low. The phytosterols were found to be stable in a stock solution for 24 hrs (percentage relative standard deviation was below 2%)and no interfering extra peaks were observed under controlled stress conditions.Conclusion: The proposed method is simple, specific, precise, accurate, and reproducible and thus can be used as appropriate method for routineanalysis of X. strumarium phytosterols in quality control laboratories.Keywords: Xanthium strumarium, Reverse phase high-performance liquid chromatography method, Precision, Phytosterols, Quality control.


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>


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