scholarly journals A VALIDATED ANALYTICAL HPLC METHOD FOR THE QUANTIFICATION OF LINCOMYCIN HYDROCHLORIDE IN BULK AND SOLID DOSAGE FORM

2017 ◽  
Vol 9 (3) ◽  
pp. 42
Author(s):  
P. Rajeev Kumar ◽  
Rekha Rajeevkumar

Objective: Develop a simple isocratic reverse phase high performance liquid chromatographic method (RP-HPLC) and validate for the determination of lincomycin hydrochloride (LMH) in bulk and pharmaceutical preparations.Methods: RP-HPLC quantification was carried out by using fine pack SIL RPC18 column. The mobile phase (methanol: water) was pumped at a flow rate of 1 ml/min in the ratio of 90:10 v/v and the eluents were monitored at 254 nm.Results: The retention time of the drug was 3.73 min and produced at a linear response in the concentration range of 5-25µg/ml. The percentage RSD was found to be below 2%. The LOD and LOQ were found to be 0.854µg/ml and 0.258µg/ml respectively.Conclusion: Validation of the method was performed for precision, accuracy, linearity, ruggedness, specificity and sensitivity to conform to ICH guidelines for valuation for analytical methods.

Author(s):  
M. Murali ◽  
P. Venkateswara Rao

A simple, selective, linear, precise and accurate isocratic RP-HPLC method was developed and validated for rapid assay of Vandetanib, an anticancer drug, in both bulk and tablet dosage form. Elution at a flow rate of 1ml/min was employed on a symmetry C18 column at ambient temperature. The mobile phase consisted of acetonitrile, water and orthophosphoric acid in the ratio of 90:08:02 (v/v/v). Linearity was observed in concentration range of 50-200 ppm. The retention time for Vandetanib was 3.326 min. The method was validated as per the ICH guidelines. The proposed method can be successfully applied for the estimation of Vandetanib in pharmaceutical dosage forms. Moreover the detection alone was also verified through LC-MS of the Vandetanib drug using ESI method which provides future scope for study of this drug using LC-MS method also.


Author(s):  
Zahid Zaheer ◽  
Sarfaraz Khan ◽  
Mohammad Sadeque ◽  
Hundekari G. I. ◽  
Rana Zainuddin

A simple, reproducible and efficient reverse phase high performance liquid chromatographic method was developed for Lisinopril in bulk drug and formulation. A column having 150 × 4.6 mm in isocratic mode with mobile phase containing acetonitrile: phosphate buffer (70:30; adjusted to pH 3.0) was used. The flow rate was 0.8 ml/min and effluent was monitored at 216 nm. The retention time (min) and linearity range (μg/ml) for Lisinopril was (1.510) and (10-35). The developed method was found to be accurate, precise and selective for determination of Lisinopril in bulk and formulation.


2021 ◽  
Vol 19 (7) ◽  
pp. 196-208
Author(s):  
H.N.K. AL-Salman ◽  
Ekhlas Qanber Jasim ◽  
Hussein H. Hussein

Objective: The current study aims to find a suitable, accurate, and faster RP-HPLC technique for the determination of theophylline, which could then be validated in accordance with the International Conference on Harmonization (ICH) guidelines. The Aim of this Study: The aim of this study was to develop an efficient, accurate, and faster RP-HPLC method for determining theophylline, which was then validated using the International Conference on Harmonization (ICH) guidelines. Methods: In the HPLC analysis, the Waters 2695 was used. The drug was isolated better using an Ion Pac zorbax 300-SCX Agilent Column, 5 m, 4.6 250 mm, with a liquid phase of Orthophosphoric acid (0.1 percent Orthophosphoric acid in HPLC acetonitrile and Methanol in the ratio of 50:50 v/v at a flow rate of 1ml/min, with discovery at 280 nm using a PDA detector. Results: Theophylline's preservation time was discovered to be 3.747 0.127 min. In the 5-25 mg/l range, the procedure was found to be linear, with a parallel coefficient (R2) of 0.9998. The LOD and LOQ of the system were determined to be (0.99 and 3) g/ml, respectively. The technique and system precisions were predicted using, and the outcomes were determined as percent RSD principles, which were noticed to be within the strict limitations. Theophylline recovery was detected to be in the 99-100 percent range, confirming the method's precision. Conclusion: Using basic ICH guidelines, the suggested RP-HPLC process was validated. The following methodology can be used successfully and easily for routine diagnostic analysis.


INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (05) ◽  
pp. 61-64
Author(s):  
A. L Rao ◽  
◽  
R. V Bhaskara

A reverse phase high performance liquid chromatographic method was developed and validated asper ICH guidelines for estimation of trandolapril and verapamil in combined tablet dosage form. Theseparation was obtained using a mobile phase consisting of acetonitrile and phosphate buffer adjustingpH to 3.0 in the ratio of 70:30 v/v and using Waters C18 (250 x 4.6 mm, 5 mcm) column maintained atambient temperature. The flow rate was 1.2 mL min-1 and UV detection was monitored at 215 nm. Theretention time (min) and linearity range (mcg mL-1) for trandolapril and verapamil were (5.12, 2.70) and(20-60, 20-60), respectively. The method validation results are within the acceptance criteria for precision,accuracy and linearity. The proposed method was found to be suitable for routine quality control ofmarketed formulation containing these APIs.


2021 ◽  
Author(s):  
Vilas K. Patil ◽  
Nilesh D. Dhande ◽  
Narendra H. Petha ◽  
Hemant P. Narkhede

A simple derivatization reverse-phase high performance liquid chromatographic method for the simultaneous analysis (separation and quantification) of zineb and hexaconazole has been optimized and validated.


2010 ◽  
Vol 7 (3) ◽  
pp. 827-832 ◽  
Author(s):  
R. Kalaichelvi ◽  
B. Thangabalan ◽  
D. Srinivasa Rao

A rapid, simple and validated reversed-phase high-performance liquid chromatographic method has been developed for analysis of aripiprazole in tablet dosage form. Aripiprazole was separated on an ODS analytical column with a 40:60 (v/v) mixture of acetonitrile and triethanolamine buffer (5 mM, pH 3.5 ± 0.05 adjusted by addition of 85% phosphoric acid) as mobile phase at a flow rate of 1.5 mL min-1. The effluent was monitored by UV detection at 254 nm. Calibration plots were linear in the range of 20 to 60 µg mL-1and the LOD and LOQ were 0.411 and 1.248 µg mL-1, respectively. The high recovery and low relative standard deviation confirm the suitability of the method for routine quality control determination of aripiprazole in tablets.


INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (06) ◽  
pp. 63-68
Author(s):  
R. Raut ◽  
◽  
A. Patil ◽  
V. K Munipalli ◽  
M. Patel ◽  
...  

A simple precise and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for quantitative determination of Regorafenib in tablet dosage form. In this method Hypersil Gold (C18, 150mm× 4.6mm id, 3μ) column with mobile phase consisting of Trifluoroacetic acid (0.2% v/v) and Acetonitrile in the ratio of (50: 50 v/v) at 400C in an isocratic mode was used. The detection was carried out at 260 nm and 20μL injection volume was selected with the flow rate 1mL/min. The linearity range of Regorafenib shows concentration between 5-200 μg/mL. The regression coefficient obtained was 0.999. Retention time of Regorafenib was found to be 6.49 minutes. Acetonitrile and Water in the ratio of (3:1) was used as a diluent. The method was validated as per ICH guidelines and is simple, fast, accurate, precise and can be applied for routine quality control analysis of Regorafenib in tablet dosage form.


INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (07) ◽  
pp. 43-49
Author(s):  
B.P. Manjula ◽  
V. G Joshi ◽  
Siddamsetty Ramachandra Setty ◽  
M Geetha ◽  

Tea tree oil, an active ingredient of skin, hair and nail care cosmeceuticals, has claims for topical antimicrobial, analgesic and anti-inflammatory activity. Its complex composition is governed by ISO 4730:2017. Terpinene-4-ol is the principal constituent of the oil (35% - 48%) followed by γ-terpinene (14% -28%), α-terpinene (6%-12%) and 1,8-cineole (≤15%). A reversed-phase, isocratic high performance liquid chromatographic method has been developed and validated for routine determination of tea tree oil based on1,8-cineole content in bulk and commercially available cosmeceuticals using C18 column, methanol-water (70:30 v/v) as mobile phase and flow rate of 1mL/min. UV detection was done at 200 nm. Linearity of the method was established for 20-100μL/mL (R2 = 0.9992) with LOD, LOQ values of 0.5594 μL/mL and 5.5941μL/mL respectively. The % RSD values for robustness and precision were <1% and recovery ranged between 99.09-102.96%. The method was successfully applied for determination of 1,8-cineole content in cosmeceuticals.


Author(s):  
Zubaidur Rahman ◽  
Vijey Aanandhi M ◽  
Sumithra M

Objective: A simple, novel, sensitive, rapid high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for quantitative determination of atomoxetine HCl (ATH) in bulk and formulations.Methods: The chromatographic development was carried out on RP-HPLC. The column used as Xterra RP 18 (250 mm × 4.6 mm, 5 μ particle size), with mobile phase consisting of methanol: water 80:20 V/V. The flow rate was 1.0 mL/min and the effluents were monitored at 270 nm.Results: The retention time was found to be 5.350 min. The method was validated as per International Conference on Harmonization Guideline with respect to linearity, accuracy, precision, and robustness. The calibration curve was found to be linear over a range of 2–10 μg/mL with a regression coefficient of 0.9999. The method has proved high sensitivity and specificity.Conclusion: The results of the study showed that the proposed RP-HPLC method was simple, rapid, precise and accurate which is useful for the routine determination of ATH in bulk drug and in its pharmaceutical dosage form.


2017 ◽  
Vol 15 (2) ◽  
pp. 187-194 ◽  
Author(s):  
Md Shahadat Hossain ◽  
Md Samiul Islam ◽  
Subrata Bhadra ◽  
Abu Shara Shamsur Rouf

Highly nutritious dairy products are ingested regularly by all ages of population. Adulteration of dairy products to enhance the inherent stability and acceptability to common consumers by different harmful and toxic ingredients like formalin, an unpermitted preservative, has been a burning issue in Bangladesh over the last few years. The aim of this paper was to analyze the concentration of formaldehyde in dairy products most commonly sold in Bangladeshi markets by a validated reversed phase high performance liquid chromatographic (RP-HPLC) method to reveal the on-going alarming scenario in a scientific way. After pre-derivatization with 2,4- dinitrophenylhydrazine, formaldehyde was detected at 345 nm using a C18 column with acetonitrile and water (45:55) as mobile phase at a flow rate of 2.0ml/min. The validated method has been applied to 41 marketed dairy products, including pasteurized milk, UHT milk, banana- mango- and chocolate-milk, flavored yoghurt, lassi, buttermilk, and skimmed milk. However, no formaldehyde was detected among the tested dairy products.Dhaka Univ. J. Pharm. Sci. 15(2): 187-194, 2016 (December)


Sign in / Sign up

Export Citation Format

Share Document