Development and validation of RP-HPLC method for the determination of doxycycline hyclate in spiked human urine and pharmaceuticals

نویسندگان

  • Pavagada J. Ramesh
  • Kanakapura Basavaiah
  • Kalsang Tharpa
  • Kanakapura Basavaiah Vinay
چکیده

An accurate, sensitive, precise, rapid, isocratic reversed phase HPLC (RP-HPLC) method for the determination of doxycycline hyclate in bulk drug and in tablets, and also in spiked human urine, was developed and validated. The best separation was achieved on a 250 mm × 4.0 mm i.d, 5.0 μm particle size C8 reversed phase thermo column with acetonitrile-potassium dihydrogenorthophosphate buffer (pH 4.0), 40:60 (v/v) as mobile phase at a flow rate of 1.0 mL/min. UV detection was performed at 325 nm at ambient column temperature (25 °C). The method was linear over the concentration range of 30-300 μg/ mL (r=0.9994) with limits of detection and quantification of 0.02 and 0.1 μg/ mL, respectively. The drug was subjected to oxidation, acid and base hydrolysis, photolysis and heat as stress conditions. Degradation products were found interfering with the assay of doxycycline hyclate only in oxidation and base hydrolysis, therefore the method can be regarded as indicating stability in the case of acid hydrolysis, photolysis and heat stress conditions. The method was applied for determination of doxycycline hyclate in pharmaceuticals and spiked human urine with excellent recoveries. The method can be used for the quality control of doxycycline hyclate.

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

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Selective Spectrophotometric Determination of Metformin Hydrochloride in Pharmaceuticals and Urine Using Two Nitrophenols as Chromogenic Agents

      Metformin hydrochloride (MFH) is an oral anti-diabetic drug of biguanide class. Two selective spectrophotometric methods were presented for the determination of MFH in pharmaceuticals. The methods were based on the measurement of yellow-coloured charge-transfer complexes formed between MFH and two poly-nitrophenols, namely, 2,4-dinitrophenol (DNP method, at 405 nm) and picric acid (PA met...

متن کامل

Simultaneous RP-HPLC and UV Spectroscopic Method Development and Validation for Estimation of Ibandronate Sodium in Bulk and Pharmaceutical Dosage Form

The present study describes a simple, accurate, precise and cost effective UV-Vis Spectroscopic and RP-HPLC method for the estimation of Ibandronate sodium (IBN). The determination of Ibandronate sodium (IBN) was performed by both UV and RP-HPLC method using 215 nm as the determination wavelength. The drug was dissolved in NaOH solution (0.1N NaOH) for estimation in UV and in distilled water fo...

متن کامل

Development and validation of a fast, simple and specific stability indicating RP-HPLC method for determination of Dexpanthenol in eye gel formulation.

AIn this study a simple and reliable stability-indicating RP-HPLC method was developed and validated for analysis of Dexpanthenol in an artificial tear formulation. The chromatographic separation was performed on a HPLC C18 column (25.0 cm  4.6 mm, 5 m) using a mixture of 0.037 M monobasic potassium phosphate in water (adjusted with 0.1% (v/v) phosphoric acid to a pH of 3.2) and methanol (90:...

متن کامل

Development and validation of a fast, simple and specific stability indicating RP-HPLC method for determination of Dexpanthenol in eye gel formulation.

AIn this study a simple and reliable stability-indicating RP-HPLC method was developed and validated for analysis of Dexpanthenol in an artificial tear formulation. The chromatographic separation was performed on a HPLC C18 column (25.0 cm  4.6 mm, 5 m) using a mixture of 0.037 M monobasic potassium phosphate in water (adjusted with 0.1% (v/v) phosphoric acid to a pH of 3.2) and methanol (90:...

متن کامل

Development and Validation of a HPLC Method for Determination of Pefloxacin in Tablet and Human Plasma

Objective(s) Developing and validating a simple, efficient, reproducible and economic reversed phase high performance liquid chromatographic (RP-HPLC) method for the quantitative determination of pefloxacin in bulk material, tablets and in human plasma. Materials and Methods A shim-pack CLC-ODS column and a mobile phase constituting acetonitrile: 0.025 M phosphoric acid solution (13:87 v/v, ...

متن کامل

ذخیره در منابع من


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

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

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره   شماره 

صفحات  -

تاریخ انتشار 2011