Validated stability indicating HPLC method for estimation of theophylline from a novel microsphere formulation

Abstract

A new, simple, specific, precise and robust isocratic reversed-phase (RP) stability-indicating high-performance liquid chromatographic (HPLC) method was developed and validated for determination of theophylline from a novel formulation. The liquid chromatographic separation was achieved isocratically using a mobile phase of acetonitrile: 50 mM sodium acetate buffer (15:85) adjusted to pH 6.5 using dilute hydrochloric acid. The analysis was carried out using Hi-Q-Sil C18 column [250 mm x 4.6 mm, 5 µm] at flow rate of 1 ml/min and the UV detection at 270 nm. The method was validated for accuracy, precision, linearity, range, selectivity, and robustness. The linearity of the proposed method was investigated in the range of 1 to 24 µg/ml (r 2 = 0.9995). The drug was subjected to oxidation, hydrolysis, heat, and photolysis to apply stress conditions. The method provided good peak parameters with retention time of 8.6 ± 0.3 min. Degradation products resulting from stress studies did not interfere with the detection of theophylline and the assay can thus be considered as stability-indicating.

A Novel HPLC Method Validation Based on Analytical Techniques of Metoclopramide Benzamide Derivative (Metoclopramide Base) and its Determination from Solid Dispersion by Solvent Evaporation Method

“…They reported the retention time for metoclopramide hydrochloride as 7.5 min. (Singh and Singh, 2012) carried out HPLC analysis in a mixture of drugs in which reported retention time for metoclopramide hydrochloride was longer (10.8 min). Duration of retention time depends on many factors such as: physicochemical properties of testing sample, solvents, flow rate, temperature, pH, column pressure and column characteristics.…”

“…PVP loaded SD is generally produced by solvent evaporation method due to its high melting point ~130°C (Zhai et al, 2017). By using UV detector lot of investigations were carried out for the purpose of detection of higher dose medications (Shidhaye et al, 2009). Lamparczyk and his co-workers (Lamparczyk et al, 2001) had developed a method to detect low amount of analyte in serum by HPLC with electrochemical detector.…”

“…Lamparczyk and his co-workers (Lamparczyk et al, 2001) had developed a method to detect low amount of analyte in serum by HPLC with electrochemical detector. Most of the HPLC studies were accomplished with water soluble hydrochloride form of metoclopramide as dosage forms which are widely available in the market (Radwan, 1998;Deokate and Gorde, 2014;Shidhaye et al, 2009;Freudling and Vergin, 1983;Riley, 1984). Conversion of hydrochloride to base form causes deprotonation and gives rise to lipophilic form of metoclopramide.…”

“…occurred to be much typical for oral administration of high dose metoclopramide to adults (under thirty) as well as to adolescents (Riley, 1984). Some reports are also available based on simultaneous detection of metoclopramide along with other drugs (Vamsikrishna et al, 2014;Singh and Singh, 2012;Hegazy et al, 2013). There is dearth of report on HPLC method for the detection of low amount of metoclopramide base by UV detector.…”

Stability-indicating RP-HPLC method for simultaneous estimation of levosalbutamol sulfate and theophylline in combined dosage form

“…Whereas for levosalbutamol sulfate a few spectrophotometric Thulasama et al, 2009) and HPLC (Ghemud et al, 2012;Halabi et al, 2004; methods are reported. The reported methods for theophylline includes spectrophotometric (Abuirjeie et al, 1992;Bermejo et al, 1985;Carter et al, 1985;Fellenberg et al, 1979;Hohnadel et al, 1978;Jatlow, 1975;Kumar et al, 2011;Plavsic, 1978;Vasiliades et al, 1976), HPLC (Abuirjeie et al, 1992;Boberic-Borojevic et al, 1999;Greenberg et al, 1979;Lauff, 1987;Moncrieff, 1991;Papadoyannis et al, 1993;Shidhaye et al, 2009), GC (Chrzanowski et al, 1974;Schwertner, 1979;Shah et al, 1974) and LC-MS (Abdel-Hamid et al, 2003;Babu et al, 2011;Kanazawa et al, 2000;Song et al, 2004). The literature survey suggests there is lack of a stability indicating RP-HPLC method for simultaneous determination of levosalbutamol sulfate and theophylline in combined syrup dosage forms.…”