Development and validation of RP-HPLC method for the estimation of omeprazole in bulk and capsule dosage forms

Abstract

A method for the determination of omeprazole in bulk and capsule dosage form by reverse phase high performance liquid chromatography has been developed. This is a simple, rapid, precise and an accurate method. The method was developed on a Novapak C18, (250 x 4.6 mm, 5µ) column using phosphate buffer (pH 7.4) and acetonitrile in the ratio of 60:40, v/v as a mobile phase which was pumped at a flow rate of 1.0 ml/min and detection was done at 302 nm. The retention time of the drug was found to be 7.71 min. The method was validated for accuracy, precision, linearity, specificity, robustness. The linearity was observed in the range of 20-60 ppm. The results of recovery studies indicated that the method was accurate. Hence the developed method was found to be suitable for the estimation of omeprazole in bulk and capsule dosage forms.DOI: http://dx.doi.org/10.3329/icpj.v1i11.12062 International Current Pharmaceutical Journal 2012, 1(11): 366-369

Stability Study and Validated Reversed Phase Liquid Chromatographic Method for the Determination of Tirofiban Hydrochloride in Presence of Tyrosine as a Process Impurity

“…Several analytical methods have been described in literature for the determination of TIR in bulk, pharmaceutical and biological samples. These methods include UV spectrophotometry [4,5], HPLC [5][6][7][8][9], LC-MS [10,11] and TLC [5].…”

A new study on Omeprazole spectrophotometric determination using 9- Fluorenylmethyl chloroformate as derivatizating agent

“…In the reaction optimization, some variables have been taken in the consideration that have great effect on the absorbance in order to get the higher, stable, and clear peak with good yield of product and fast preparation procedure of derivatization (Table 1). 5.0µg/mL FMOC-Cl spectrum in the reaction medium has three absorbance peaks (206, 264, 300nm), the 10.0µg/mL of OMZ has maximum absorbance 0.164 at 300nm, and the derivatization product profile has two absorbance region (217, and 300nm) and it is clearly observed that the absorbance peak has increased. Effect of the pH pH of the medium affects both FMOC-Cl and OMZ, in the alkaline media OMZ generates nucleophile and so the nucleophilic substitution reaction with FMOC-Cl will take a place, 29 also OMZ decomposes in the acidic media.…”

“…Literature survey revealed that, there are several publication of omeprazole quantitative determination either individually or combined dosage form using various techniques, for instance, LC-MS/MS procedure for determination in drugs and metabolites in biological liquids such as urine and plasma, UPLC with UV detection method for determination of omeprazole in omeprazole magnesium blend, 3 FT-IR spectroscopic determination of omeprazole in combined dosage form, 4 RP-HPLC methods of determination, [5][6][7][8][9] HPLC quantitative methods of determination, [10][11][12][13][14] Capillary electrophoresis, 15 electrochemical methods, [16][17][18][19] spectrofluorometric methods 20 and spectrophotometric methods. [21][22][23][24][25][26][27] However, some methods have low sensitivity and accuracy.…”

Generation and Characterization of Novel Delayed Extended Release Co-Processed Excipient With Gastric Stabilizing Activity

“…It has been suggested that sustained release dosage form of omeprazole may prolong the drug release for extended period of time and provide better therapeutic efficacy by inhibiting the regeneration of H + /K + -ATPase for longer duration (more than 3 days) in chronic acid related disorders. [11,13] In the present study, attempts have been made to develop co-processed pH dependent polymer for omeprazole drug in acidic environment as a stable delayed release tablet formulation and may give local effect in duodenal ulcer, reduced drug loss and also reduced dosing frequency due to sustained release of drug from the matrix.…”

“…[13] Instruments and reagents A prominence isocratic HPLC system (youngling HPLC YL 9000 series) with YL 9110 pump with autochro 3000 software and UV-VIS detector YL 9120 was used. Potassium dihydrogen orthophosphate and dipotassium hydrogen phosphate were of AR grade and acetonitrile and water of HPLC grade were used.…”