lornoxicam (jurnal pendukung)

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Review Article

A Review On Paracetamol & Lornoxicam

Tanushree Banerjee 1*, Bhaskar Banerjee 1 & Angshu Banerjee 2

1 Department of Pharmaceutical Chemistry, RKDF College of Pharmacy, Bhopal (M.P.), India.2 Department of Pharmaceutical Chemistry, Balaji College of Pharmacy , Jaipur, (Raj.), India.

Received: 27 October 2011; Revised: 17 November 2011; Accepted: 28 November 2011

Abstract: The review describes about some qantitative estimation of Paracetamol and Lornoxicam in bulk andtablet formulation. The quantitation was carried out by simultaneous equation method, absorption ratio method,

stability indicating reversed phase high performance liquid chromatographic method, Reverse Phase HighPerformance Liquid Chromatographic method, and High Performance Thin Layer Chromatography method. Allthe methods were validated.

Keywords : Paracetamol, Lornoxicam, formulation, reversed phase high performance liquid

INTRODUCTION:

Paracetamol is a preparation of acetylated aromatic amide group, for the first time presented byvon mering in the year 1893. [1] Chemically, Paracetamol is 4-hydroxy acetanilide, [Figure 1A] usedas an analgesic and antipyretic drug and used for the treatment of pain such as headache, toothache,

rheumatism and neuralgia. Paracetamol is official in I.P, B.P and USP [2]. Paracetamol is freelysoluble in solutions of Ethanol and Acetone, Sparingly soluble in water, very slightly soluble inDichloromethane, Ether. Molecular weight of Paracetamol is 151.6 and Meltind Point is 169-170.5 oC.Lornoxicam is 6-chloro-4-hydroxy-2-methyl-N-2-pyridinyl-2H-thieno[2,3-e]1,2thiazine-3-carboxamide 1,1-dioxide [Figure 1B] . Lornoxicam is a novel non-steroidal anti inflammatory drug inthe enolic acid class of compound with analgesic, anti inflammatory and antipyretic properties. Itworks by blocking the action of Cyclooxygenase, an enzyme involved in the production of chemicals,including some prostaglandins in the body [3]. Analytical methods have been reported for thedetermination of Lornoxicam includes HPLC, UV-Spectrophotometric, Polarographic, Voltammetric.LC/MS/MS, TLC-densitometry method were reported for the analysis of lornoxicam [4].

Estimation of Paracetamol and Lornoxicam by Spectrophotometric Quantitative Method inCombined Dosage Form: Two accurate, precise, sensitive and economical spectrophotometricmethods were developed and validated for simultaneous estimation of Lornoxicam and Paracetamol intablet dosage form. These methods were developed based on the simultaneous estimation of drugs in abinary mixture without previous separation. The methods employed were Absorbance Ratio Method(Q Analysis) (I) and Simultaneous Equation Method (Vierodt’s Method) (II). The first methodemploys 271.5 nm as λ 1 (Isobestic point) and 286 nm as λ 2 (λ max of Lornoxicam) for formation ofequations. The second method employs estimation of a drug concentration by selecting λ max wherethe absorbances of these drugs were maximum. So λ max for Lornoxicam and Paracetamol is 286 nmand 257 nm respectively. Lornoxicam and Paracetamol obey Beer’s law in the concentration range 8-



40 µgml -1 (r2 = 0.9998) and 10-50 µgml -1 (r2 = 0.9999) in 0.1 N NaOH. The mean recovery forLornoxicam and Paracetamol were found to be 98.38±1.28% and 100±0.50% from method I and100.33±0.56% and 100±0.40% from method II [Figure 2][5]

A simple and sensitive spectrophotometric method has been developed for simultaneousdetermination of Paracetamol and Lornoxicam in a binary mixture. In the proposed method, theabsorbances were measured at 257.0 nm and 287.0 nm corresponding to the absorbance maxima ofParacetamol and Lornoxicam in 0.1 N NaOH respectively. Linearity range was observed in theconcentration range of 5-30 µg/ml for Paracetamol and 2-10 µg/ml for Lornoxicam. Concentration ofeach drug was obtained by using the absorptivity values calculated for both drugs at two wavelengths,257.0 nm and 287.0 nm and solving the simultaneous equation. Developed method was applied tolaboratory mixture and its marketed formulation. The method was validated statistically and recoverystudy was performed to confirm the accuracy of the method. The method was found to be rapid,simple, accurate and precise [Figure 3] [6]

Stability Indicating Studies on LC-Method: Stability indicating reversed phase high performanceliquid chromatographic method was developed for the simultaneous determination of paracetamol andlornoxicam in tablet dosage form. A Brownlee C-18, 5 µm column having 250×4.6 mm i.d. in isocraticmode, with mobile phase containing 0.05 M potassium dihydrogen phosphate:methanol (40:60, v/v)was used. The flow rate was 1.0 ml/min and effluents were monitored at 266 nm. The retention timesof paracetamol and lornoxicam were 2.7 min and 5.1 min, respectively. The linearity for paracetamoland lornoxicam were in the range of 5–200 µg/ml and 0.08–20 µg/ml, respectively. Paracetamol andlornoxicam stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation and dryheat degradation [Figure 4] [7]

Isocratic RP-HPLC: Reverse Phase High Performance Liquid Chromatographic method with in vitro dissolution assessment was developed for simultaneous estimation of Paracetamol and Lornoxicam inTablet. 25 cm × 4.6 mm i.d, 5- µm particle; Phenomenex Luna C18 reversed-phase column, withmobile phase, ethyl acetate: Methanol: Water (2.5:70:28.5 v/v), pH was adjusted to 4.0 with aceticacid. The flow rate was 1.0 ml/min and individual component were measured at 234 nm. The retentiontime of Paracetamol and Lornoxicam was 4.350 and 7.23 respectively. The method was validated interms of accuracy, precision, linearity, limit of detection, limit of quantitation, robustness andruggedness as per ICH and USP guidelines. The in vitro release of various test units was compared fortheir similarity using the f 2 test which limits were found within the acceptance criteria. The assay and

recovery studies show Paracetamol and Lornoxicam in the range from 99 to 101 % were obtained atvarious added concentrations. Ambroxol was used as an internal standard. The procedures weresuccessfully applied for simultaneous determination of both drugs in laboratory prepared mixtures aswell as commercial tablet dosage form[8] [Figure 5]

High Performance Thin Layer Chromatographic Study: Densitometric method for determinationof Paracetamol and Lornoxicam in combined tablet dosage form has been developed and validated.Separation of the drugs was carried out using Toluene: Methanolic NaOH: Glacial acetic acid (7:2:1.5,v/v/v) as mobile phase on precoated Silica gel 60 F 254 plates. The retention factors for Paracetamol andLornoxicam were found to be 0.47 ± 0.02 and 0.67 ± 0.02 respectively. The densitometric evaluation

of bands was carried out at 265 nm. The calibration curve was linear in the concentration range 100 to



600 ng/band for both the drugs. The method has been successfully applied for the analysis of drugs inpharmaceutical formulation. The (%) assay (Mean ± S.D.) was found to be 99.93 ± 0.48 forParacetamol and 100.04 ± 0.68 for Lornoxicam respectively [9] [Figure 6, 7]

Figure – 1 Chemical Structures of [A] Paracetamol [B] Lornoxicam.

Figure - 2 Overlay Spectra of Lornoxicam and Paracetamol

Figure – 3 Overview of Paracetamol and Lornoxicam Spectra



Figure – 4 Liquid Chromatogram of Paracetamol and Lornoxicam

Figure – 5 RP-HPLC Chromatograms of Paracetamol, Lornoxicam and Ambroxol (internalstandard)

Figure – 6 Overlain Spectra of Paracetamol and Lornoxicam

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