stability-indicating uflc method for uncoupling and estimation of impurities in clopidogrel, aspirin and omeprazole in their tablet dosage form using pda detection

نویسندگان

jinesh nagavi

jss college of pharmacy ss nagara bannimath gurupadayya

jss college of pharmacy

چکیده

in this paper a fast and novel stability-indicating ultra fast lc method for separation and estimation of impurities in clopidogrel and aspirin in their combined tablet dosage form and omeprazole was developed. the separation of usp related substances of clopidogrel (a, b and c), aspirin (d), omeprazole (a, b and c) and few other unknown impurities was detected by using ultra fast liquid chromatography with pda detection. the maximum detection was set as follows: 237 nm for aspirin, its impurities and for the impurity c of clopidogrel and 254 nm for clopidogrel and its impurities except for impurity c and 280 nm for omeprazole and its impurities. phenomenex c8 (250 mm × 4.6 mm, 5µ) was used as a stationary column to separate and analyze the mixture within 11 min with a programmed gradient elution of 0.01 m phosphate buffer ph 2.0 and acetonitrile. the method was successfully validated in accordance to the international conference of harmonization (ich) guidelines for clopidogrel and its impurities, aspirin and its impurity d and omeprazole and its impurities a, b and c. the tablets were exposed to acid, alkaline, thermal, higher humidity, oxidative and photolytic stress conditions. samples undergone stressed conditions were analyzed by the novel proposed method. separation was satisfactory for all the significant degradation products from the principal peaks of drug substances and the impurities from each other. the method complies for the peak purity test for clopidogrel, aspirin and omeprazole in all the samples under stress and showed no co-elution of degradation products. the method was found to be stable, precise, linear, accurate, sensitive, specific and robust. the method can be used routinely to test the adulteration in the pharmaceutical formulations of clopidogrel, aspirin, and omeprazole.

برای دانلود باید عضویت طلایی داشته باشید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Stability-indicating UFLC method for uncoupling and estimation of impurities in clopidogrel, aspirin and omeprazole in their tablet dosage form using PDA detection

In this paper a fast and novel stability-indicating ultra fast LC method for separation and estimation of impurities in clopidogrel and aspirin in their combined tablet dosage form and omeprazole was developed. The separation of USP related substances of clopidogrel (A, B and C), aspirin (D), omeprazole (A, B and C) and few other unknown impurities was detected by using ultra fast liquid chroma...

متن کامل

New Stability-Indicating RP-UFLC Method for Determination of Trospium Chloride in Tablet Dosage Form

A simple, precise, and accurate isocratic RP-UFLC stability-indicating assay method has been developed to determine trospium chloride in tablet dosage form. Isocratic separation was achieved on an Enable-C18G (250 mm × 4.6 mm i.d., particle size 5 μm) column at room temperature, the mobile phase consisted of acetonitrile:0.01M TBAHS (50:50, v/v) at a flow rate of 1.0 ml/min, the injection volum...

متن کامل

Stability Indicating Rp-hplc Method for Simultaneous Determination of Aspirin and Clopidogrel in Dosage Form

Stability-indicating High Performance Liquid Chromatographic (HPLC) method was developed for simultaneous Aspirin and Clopidogrel, A Phenomenex Gemini C-18, 5 μm column having 250mm x 4.6 mm i.d. in isocratic mode, with mobile phase containing buffer solution 0.3% orthophosphoric acid : acetonitrile (65: 35, v/v). The flow rate was 1 ml/min and effluents were monitored at 266 nm. For linearity ...

متن کامل

Validated and Stability Indicating Liquid Chromatography Method for Quantification of Bisoprolol Fumarate in Tablet Dosage Form

A simple and accurate liquid chromatographic method was developed and validated for the analysis of bisoprolol fumarate in tablets. Chromatographic separation was achieved on a C18 column utilizing a mobile phase of buffer/acetonitrile (75:25, v/v, pH 5.6) at a flow rate of 1.0 mL/min. The separation was performed at room temperature. Detection was carried out at 226 nm, using a diode array det...

متن کامل

A Simple and Specific Stability- Indicating RP-HPLC Method for Routine Assay of Adefovir Dipivoxil in Bulk and Tablet Dosage Form

A simple and reliable stability-indicating RP-HPLC method was developed and validated for analysis of adefovir dipivoxil (ADV).The chromatographic separation was performed on a C18 column using a mixture of acetonitrile-citrate buffer (10 mM at pH 5.2) 36:64 (%v/v) as mobile phase, at a flow rate of 1.5 ml/min. Detection was carried out at 260 nm and a sharp peak was obtained for ADV at a reten...

متن کامل

Stability-indicating Simultaneous HPTLC Method for Olanzapine and Fluoxetine in Combined Tablet Dosage Form

A rapid, selective and stability-indicating high performance thin layer chromatographic method was developed and validated for the simultaneous estimation of olanzapine and fluoxetine in combined tablet dosage form. Olanzapine and fluoxetine were chromatographed on silica gel 60 F(254) TLC plate using methanol:toluene (4:2 v/v) as the mobile phase and spectrodensitometric scanning-integration w...

متن کامل

منابع من

با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید


عنوان ژورنال:
iranian journal of pharmaceutical sciences

جلد ۱۲، شماره ۲، صفحات ۴۳-۶۰

کلمات کلیدی

میزبانی شده توسط پلتفرم ابری doprax.com

copyright © 2015-2023