Simultaneous Determination of Piracetam and its Four Impurities by RP-HPLC with UV Detection

Abstract

A simple and rapid high-performance liquid chromatographic method for the separation and determination of piracetam and its four impurities, 2-oxopyrrolidin-1-yl)acetic acid, pyrrolidin-2-one, methyl (2-oxopyrrolidin-1-yl)acetate, and ethyl (2-oxopyrrolidin-1-yl)acetate, was developed. The separation was achieved on a reversed-phase C(18) Nucleosil column (25 cm x 0.46 cm, 10 microm). The mobile phase is composed of an aqueous solution containing 0.2 g/L of triethyl amine-acetonitrile (85:15, v/v). The pH of the mobile phase was adjusted to 6.5 with phosphoric acid at a flow rate of 1 mL/min at ambient temperature and UV detection at 205 nm. The developed method was found to give good separation between the pure drug and its four related substance. The polynomial regression data for the calibration plots showed good linear relationship in the concentration range of 50-10,000 ng/mL, 25-10,000 ng/mL, 45-10,000 ng/mL, 34-10,000 ng/mL, and 55-10,000 ng/mL, respectively, with r(2) = 0.9999. The method was validated for precision, accuracy, ruggedness, and recovery. The minimum quantifiable amounts were found to be 50 ng/mL of piracetam, 25 ng/mL of 2-oxopyrrolidin-1-yl)acetic acid, 45 ng/mL of pyrrolidin-2-one, 34 ng/mL of methyl (2-oxopyrrolidin-1-yl)acetate, and 55 ng/mL of ethyl (2-oxopyrrolidin-1-yl)acetate. Statistical analysis proves that the method is reproducible and selective for the estimation of piracetam as well as its related substance. As the method could effectively separate the drug from the related substances, it can be employed as a stability-indicating one. The proposed method shows high efficiency, allowing the separation of the main component piracetam from other impurities.

Development and Validation of RP-HPLC Method for Estimation of Montelukast Sodium and Fexofenadine Hydrochloride in Pharmaceutical Preparations

“…Figure 2. Structure of fexofenadine hydrochride During literature survey it was found that, various HPLC methods have been estimated for the determination of montelukast sodium [4][5][6][7] and fexofenadine hydrochloride [8][9][10][11] in combination with other drugs but no RP-HPLC method has been determined till date. Hence an attempt has been made to develop and validate a simple, economic, rapid and accurate method.…”

Validated derivative and ratio derivative spectrophotometric methods for the simultaneous determination of levocetirizine dihydrochloride and ambroxol hydrochloride in pharmaceutical dosage form

“…It is used in the treatment of upper respiratory tract diseases [5]. Some analytical methods have been reported for the determination of LCD either alone [6][7][8][9] or in combination with other drugs using high performance liquid chromatography [10][11][12][13][14][15], thin layer chromatography [16] and UV spectrophotometry [17][18][19][20][21][22]. As well, a number of methods have been reported for the individual determination of ABH [23][24][25][26][27], and in combination with other drugs in pharmaceutical dosage form by high performance liquid chromatography [28][29][30][31][32][33], liquid chromatography-mass spectroscopy/mass spectroscopy [34], thin layer chromatography [35], UV spectrophotometry [36,37] and high performance thin layer chromatography [38,39].…”

New Method Development for Hydroxyzine Determination: Application in Stability Studies, Pharmaceutical Formulations, and Humane Serum

“…Our Research Group already has done some work in the field of analytical method development for antihistamine drugs [30][31][32][33][34][35] .…”