scholarly journals A Robust Liquid Chromatographic Method for Confirmation of Drug Stability of Azithromycin in Bulk Samples, Tablets and Suspensions

2017 ◽  
Author(s):  
Alex O. Okaru ◽  
Kennedy O. Abuga ◽  
Franco N. Kamau ◽  
Stanley N. Ndwigah ◽  
Dirk W. Lachenmeier
Keyword(s):  
Degradation Products ◽  
Drug Stability ◽  
Ammonium Hydroxide ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Tetrabutyl Ammonium ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

A simple, isocratic and robust RP-HPLC method for the analysis of azithromycin was developed, validated and applied for the analysis of bulk samples, tablets and suspensions. The optimum chromatographic conditions for separation were established as mobile phase comprising of acetonitrile-0.1M KH2PO4 pH 6.5-0.1M tetrabutyl ammonium hydroxide pH 6.5-water (25:15:1:59% v/v/v/v) delivered at a flow rate of 1.0 ml/min. The stationary phase consisted of reverse-phase XTerra® (250 mm× 4.6 mm i.d., 5 µm particle size) maintained at a temperature of 43 °C with a UV detection at 215 nm. The method was found to be linear in the range 50-150% (r2=0.997). The limits of detection and quantification were found to be 0.02% (20 µg) and 0.078% (78 µg) respectively with a 100.7% recovery of azithromycin. Degradation products of azithromycin in acidic and oxidative environments at 37 °C were resolved from the active pharmaceutical ingredient and thus the method is fit for the purpose of drug stability confirmation.

scholarly journals A Robust Liquid Chromatographic Method for the Analysis of Azithromycin in Bulk Samples, Tablets and Suspensions

2016 ◽  
Author(s):  
Alex O. Okaru ◽  
Kennedy O. Abuga ◽  
Franco N. Kamau ◽  
Stanely N. Ndwigah ◽  
Dirk W. Lachenmeier
Keyword(s):  
Mobile Phase ◽  
Degradation Products ◽  
Ammonium Hydroxide ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Tetrabutyl Ammonium ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

A simple, isocratic and robust RP-HPLC method for the analysis of azithromycin was developed, validated and applied for the analysis of bulk samples, tablets and suspensions. The optimum chromatographic conditions for separation were established as mobile phase comprising of acetonitrile-0.1M KH2PO4 pH 6.5-0.1M tetrabutyl ammonium hydroxide pH 6.5-water (25:15:1:59% v/v/v/v) delivered at a flow rate of 1.0 ml/min. The stationary phase consisted of reverse-phase XTerra® (250 mm× 4.6 mm i.d., 5 µm particle size) maintained at a temperature of 43 °C with a UV detection at 215 nm. The method was found to be linear in the range 50-150% (r2=0.997). The limits of detection and quantification were found to be 0.02% (20 µg) and 0.078% (78 µg) respectively with a 100.7% recovery of azithromycin. Degradation products of azithromycin in acidic and oxidative environments at 37 °C were resolved from the active pharmaceutical ingredient and thus the method is fit for the purpose.

scholarly journals A Robust Liquid Chromatographic Method for the Analysis of Azithromycin in Bulk Samples, Tablets and Suspensions

2016 ◽  
Author(s):  
Alex O. Okaru ◽  
Kennedy O. Abuga ◽  
Franco N. Kamau ◽  
Stanely N. Ndwigah ◽  
Dirk W. Lachenmeier
Keyword(s):  
Mobile Phase ◽  
Degradation Products ◽  
Ammonium Hydroxide ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Tetrabutyl Ammonium ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

A simple, isocratic and robust RP-HPLC method for the analysis of azithromycin was developed, validated and applied for the analysis of bulk samples, tablets and suspensions. The optimum chromatographic conditions for separation were established as mobile phase comprising of acetonitrile-0.1M KH2PO4 pH 6.5-0.1M tetrabutyl ammonium hydroxide pH 6.5-water (25:15:1:59% v/v/v/v) delivered at a flow rate of 1.0 ml/min. The stationary phase consisted of reverse-phase XTerra® (250 mm× 4.6 mm i.d., 5 µm particle size) maintained at a temperature of 43 °C with a UV detection at 215 nm. The method was found to be linear in the range 50-150% (r2=0.997). The limits of detection and quantification were found to be 0.02% (20 µg) and 0.078% (78 µg) respectively with a 100.7% recovery of azithromycin. Degradation products of azithromycin in acidic and oxidative environments at 37 °C were resolved from the active pharmaceutical ingredient and thus the method is fit for the purpose.

DOMINATED RP-HPLC METHOD FOR QUALITY CONTROL OF TERNARY PHARMACEUTICAL FORMULATION: GUAIFENESIN/LEVOCETIRIZINE/ AMBROXOL HCL AND STABILITY STUDIES

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (02) ◽  
pp. 18-25
Author(s):  
Anumolu P.D ◽  
Sunitha G ◽  
Swathi N ◽  
Sri Manaswini ◽  
Radha Gayatri A ◽  
...  
Keyword(s):  
Degradation Products ◽  
Ammonium Phosphate ◽  
Oral Formulation ◽  
Hplc Method ◽  
Base Hydrolysis ◽  
Reverse Phase ◽  
Simultaneous Quantification ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

The present investigation was aimed to establish a liquid chromatographic method for simultaneous quantification of guaifenesin, levocetirizine and ambroxol HCl in ternary fixed dosage form. The three drugs were swiftly resolved using ODS C18 reverse phase column with mobile phase consisting of ammonium phosphate buffer, pH 4.5: acetonitrile (60:40, v/v) at a flow rate of 1.0 mL/min and UV detection at 236 nm. The retention time values were 2.231, 2.772 and 6.309 min, respectively, for guaifenesin, levocetirizine and ambroxol HCl. The response was a linear function of analyte over the concentration range of 12.5-75 µg/mL, 0.625-3.750 µg/mL and 3.75-22.5 µg/mL with correlation co-efficient value of 0.999. Maximum recovery (99.12-101.2 %) was obtained in ternary liquid oral formulation (Leoriv plus syrup). Three drugs were well resolved from their degradation products and net degradation was calculated in acid hydrolysis, base hydrolysis, oxidation, thermal and UV conditions. The proposed method enables the simultaneous quantification of guaifenesin, levocetirizine and ambroxol HCl in routine QC laboratories.

Validated RP-HPLC method for the estimation of Amiloride and hydrochlorothiazide in combined tablet dosage form

2021 ◽  
pp. 207-211
Author(s):  
R. Anantha Kumar ◽  
G. Raveendr Babu ◽  
Sowjanya M. ◽  
Ramayyappa M.
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Limit Of Quantitation ◽  
Phase Liquid ◽  
Tablet Dosage ◽  
Liquid Chromatographic

The aim of this work is to build up a fast, exact, precise and touchy reverse phase liquid chromatographic method for the synchronous assessment of amiloride and hydrochlorothiazide in tablet dose structure. The chromatographic strategy was normalized utilizing Hypersil ODS segment (250×4.6mm, 5μm molecule size) with UV discovery at 210nm and stream pace of 1ml/min. The portable stage includes phosphate buffer (pH acclimated to 2.5 with dilute Ortho Phosphoric acid) and acetonitrile in the proportion of 60:40 v/v. The linearity of proposed technique was examined in the scope of 5-30μg/ml (R²=0.999) for amiloride and 50-300μg/ml (R²=0.999) for Hydrochlorothiazide appropriately. The limit of detection (LOD) was discovered to be 0.10μg/ml and 0.40μg/ml for Amiloride and Hydrochlorothiazide appropriately. The limit of quantitation (LOQ) was discovered to be 0.30μg/ml and 1.20μg/ml for Amiloride and Hydrochlorothiazide separately. The retention times of Amiloride and Hydrochlorothiazide were found to be 3.258min and 2.383min separately. The technique was truly recommended and %RSD was found to be under 2 demonstrating serious level of exactness and accuracy. Subsequently proposed strategy can be effectively evaluated for the synchronous assessment of Amiloride and Hydrochlorothiazide in promoted formulations.

A simple derivatization RP-HPLC method for the simultaneous determination of zineb and hexaconazole in pesticide formulation using a PDA detector

2021 ◽  
Author(s):  
Vilas K. Patil ◽  
Nilesh D. Dhande ◽  
Narendra H. Petha ◽  
Hemant P. Narkhede
Keyword(s):  
High Performance ◽  
Chromatographic Method ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Pesticide Formulation ◽  
Liquid Chromatographic

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.

scholarly journals SIMPLE QUANTIFIED AND VALIDATED STABILITY INDICATING STRESS DEGRADATION STUDIES OF ORAL ANTI-DIABETIC AGENT DAPAGLIFLOZIN BY RP-HPLC METHOD

2022 ◽  
pp. 231-237
Author(s):  
ARULSELVAN MURUGESAN ◽  
MUKTHINUTHALAPATI MATHRUSRI ANNAPURNA
Keyword(s):  
Dosage Form ◽  
Degradation Products ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Stress Degradation

Objective: This method is focused on developing a precisely simplified and more accurate Reverse Phase–High Pressure Liquid Chromatography (RP-HPLC) method for the determination of Dapagliflozin in bulk and pharmaceutical dosage form as per guidelines of International Council for Harmonization (ICH). Methods: Evaluation and validation carried out using the RP-HPLC ZORBAX (C18) column (250 x 4.6 mm, 5 μm particle size) with a mobile phase consisting of Phosphate Buffer: Acetonitrile: Methanol in a ratio of 55:40:05 (v/v/v) at a flow rate of 1 ml/min with an injection volume of 10 μl. Results: Dapagliflozin was eluted at 2.12±0.05 min and detected at 225 nm. The regression equation y = 55762 x-29679 found to be linear with correlation coefficient r2 value of 0.9997. The developed RP-HPLC method was conveniently validated as per the ICH guidelines and found method was robust, sensitive, accurate, selective, specific, precise and linear. Conclusion: The proposed method was found to be accurate, precise, and robust for API and pharmaceutical dosage form as per experimentation analysis. The above developed method was found to be satisfied for Active Pharmaceutical Ingredient (API) and pharmaceutical formulation of Dapagliflozin to study its degradation products.

Development and Validation of RP-HPLC method for the Estimation of Ritonavir in API and tablet Formulation

2021 ◽  
pp. 5457-5460
Author(s):  
Avinash Birajdar ◽  
Varsha Tegeli ◽  
Suyash Ingale ◽  
Gajanand Nangare
Keyword(s):  
High Performance ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic

A Reverse Phase High Performance Liquid Chromatographic method has been developed and validated for estimation of Ritonavir in API and Tablet formulation. The chromatographic separation was carried out using ZOROBAX Bonus-RP C-18 column (250 x 4.6mm, 5µm) as stationary phase and Methanol: Acetonitrile: 0.1% Trifluoroacetic acid water (81:9:10) as mobile phase at 1.0 ml/min flow rate and detection was carried out at 250 nm. The method was validated accordance to the Guidelines of International Council for Harmonization (ICH). Ritonavir have linearity in the concentration range of 50-150µg/ml with correlation coefficient (r2=1) respectively. Ritonavir eluted at 3.05 min respectively. The method is sensitive, precise and accurate. So, the method can be successfully applied for the routine analysis of Ritonavir in pharmaceutical formulations.

scholarly journals ESTIMATION OF AMLODIPINE BESYLATE AND IRBESARTAN IN PHARMACEUTICAL FORMULATION BY RP-HPLC WITH FORCED DEGRADATION STUDIES

2019 ◽  
pp. 159-167 ◽  
Author(s):  
T Hemant Kumar ◽  
CH. ASHA ◽  
D. GOWRI SANKAR
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Pharmaceutical Formulation ◽  
Forced Degradation ◽  
Amlodipine Besylate ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Liquid Chromatographic

Objective: To develop and validate a simple, specific, accurate, precise and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method with forced degradation studies for the simultaneous estimation of amlodipine besylate and irbesartan in the pharmaceutical formulation. Methods: The chromatographic separation of the two drugs were achieved using Enable C 18G column (250 ×4.6 mm; 5 µm) in isocratic mode with mobile phase consisting of sodium acetate buffer (pH 4.0) and acetonitrile (30:70, % v/v) with a flow rate of 0.6 ml/min. Ultraviolet(UV) detection was carried out at 238 nm. The proposed method was validated for linearity, range, accuracy, precision, robustness, limit of detection (LOD) and limit of quantification (LOQ). The tablet formulation was subjected to stress conditions of degradation including acidic, alkaline, oxidative, thermal and photolysis. Results: The retention time for amlodipine besylate and irbesartan were found to be 5.512 and 6.321 min respectively. Linearity was observed over a concentration range 4-32 µg/ml for amlodipine besylate (r2 =0.9999) and 10-70 µg/ml for Irbesartan (r2 =0.9998). The % relative standard deviation (RSD) for Intraday and Interday precision was found to be 0.436 and 0.699 for amlodipine besylate and 0.435 and 0.30 for irbesartan. Amlodipine besylate shown stability towards acidic and thermal whereas in basic, oxidative and photolytic it shown less stability in which it degraded to more extent. Irbesartan shown stability towards thermal conditions whereas in remaining conditions it degrades to more extent especially in oxidative conditions. Conclusion: The developed reverse phase high performance liquid chromatographic (RP-HPLC) method was also found to be simple, precise and sensitive for the simultaneous determination of amlodipine besylate and irbesartan in the tablet dosage form.

scholarly journals Investigation of Formaldehyde Content in Dairy Products Available in Bangladesh by a Validated High Performance Liquid Chromatographic Method

2017 ◽  
Vol 15 (2) ◽  
pp. 187-194 ◽  
Author(s):  
Md Shahadat Hossain ◽  
Md Samiul Islam ◽  
Subrata Bhadra ◽  
Abu Shara Shamsur Rouf
Keyword(s):  
Dairy Products ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Chocolate Milk ◽  
Uht Milk ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

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)

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