Paracetamol

The aim of the current study was to isolate mucilage from five different plants, which was done by maceration, followed by incorporating the extracted mucilage into a tablet formulation and to study its disintegrant property. Comparative results were obtained and varying degree of disintegrant action was observed among the five subject plant sources. It was found that Lepidum sativum seeds showed the highest yield of 12.5%w/w as compared to the remaining four plant products. Additionally, the disintegration time of tablets formulated from mucilage obtained from Lepidum sativum was found to be the least and the tablets disintegrated in 25 seconds. Mucilages are very hydrophilic and are capable of trapping water in their cage-like structures to form a gel. Consequently, when mucilage is mixed with water it swells to many times its original volume as it absorbs water1. Mucilages find applications in numerous pharmaceutical preparations and perform their role as disintegrants, sustained-release agents, binders, mucoadhesives, to name a few2.

A new Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for estimation of Paracetamol and Alprazolam in bulk and tablet dosage forms using UV-detector. A RP Cell Pack C18 column (250 mm × 4.6 mm, 5 µ particle size) using acetonitrile and water (80:20 % V/V) as mobile phase by maintaining flow rate of 1 mL/min at 236 nm as detection wavelength. The peaks were eluted at 4.8 and 6.2 mins for Paracetamol and Alprazolam, respectively. The method was validated in accordance with ICH guidelines, the linearity curve for Paracetamol was obtained over the range of 50-175 µg/mL, and it was found to be linear with y = 1961x + 9226 (r2 = 0.999). The linearity curve for Alprazolam was obtained over the range of 0.25-1.5 µg/mL and was found to be linear with y =23328x + 939.3 (r2 = 0.998). The percentage recoveries were found to be 99-101% and 99-102%, respectively. The system suitability parameters such as number of theoretical plates and tailing factor were found to be 7242, 1.56 for PAR and 6755, 1.15 for ALP. Hence the developed RP-HPLC method was found to be simple, accurate, economical, rapid and can be applied for routine analysis of these drugs in their combined formulations.

This study examines the stability of paracetamol pediatric oral suspension (120mg/5ml) in simulated in-home storage conditions, temperature ranging from (300±5C/65±5RH) representing room condition. Samples from suspension were assayed for active pharmaceutical ingredient and tested for related substance (degradants) using B.P 2012 pharmacopeia HPLC method. The study was carried out in day zero, seven, fourteen, thirty and forty five.  The instrument utilize column ® C8, 100 x 4.6 mm, 3.5 μm particle size. The flow rate was 1.5 ml/minute. The mobile phase consisted of methanol, tetrabutylammonium hydroxide and sodium orthophosphate buffer. The results obtained showed that the drug assay content was out of the limits from day zero Furthermore, the half live was found to be 35.06 days

This study investigates the stability of paracetamol pediatric oral suspension (120mg/5ml) in simulated in-home storage conditions at temperature ranging from (2-8C0) representing refrigerator condition. Samples from suspension were assayed and tested for related substance (degradants) using B.P pharmacopeia HPLC method. The study was performed in day zero, seven, fourteen, thirty and forty five.  The instrument employs column ® C8, 100 x 4.6 mm, 3.5 μm particle size. The mobile phase consisted of methanol, tetrabutylammonium hydroxide (40 %) and sodium orthophosphate buffer. The results showed that the drug assay content remains within the limits up to day fourteen. Furthermore, the half live was found to be 36.8 days.

The Developed RP- HPLC method allows rapid and precise determinations of Cefixime  and Paracetamol. The scope of the present work is to expand and optimization of the chromatographic conditions and to develop RP-HPLC method. A series of mobile phases and columns were tried, among the various mobile phases, Buffer: Acetonitrile (65:35A) (PH-3.5) as an ideal mobile phase, since it gave a good resolution and peak shapes with perfect optimization. The flow rate was optimized at 1 ml/min. The Linearity and correlation coefficient of Cefixime and Paracetamol was found to be 0.999, and 0.999 respectively. Precision was performed and % RSD for Cefixime and Paracetamol were found to be 1.17% and 1.32% respectively. Three concentrations 50%, 100%, 150%, were injected in a triplicate manner and amount recovered and % Recovery was found to be 100%. Limit of detection was calculated by standard deviation method Cefixime and Paracetamol and LOD for Cefixime and Paracetamol were found to be 0.03and 0.02 respectively. Limit of Quantification was calculated by standard deviation method Cefixime and Paracetamol and LOQ for Cefixime and Paracetamol were found to be 0.08 and 0.06 respectively. Small deliberate changes in method like flow rate, mobile phase ratio, and temperature are made but there were no recognized change in the result and are within range as per ICH Guide lines. The average % Assay was calculated and found to be 100.46% and 99.84% for Cefixime and Paracetamol respectively. Hence, the chromatographic method developed for Cefixime and paracetamol is said to be rapid, simple, specific, sensitive, precise, accurate and reliable that can be effectively applied for routine analysis in research institutions, quality control department in Industries, approved testing laboratories, Bio-pharmaceutics and Bio-equivalence studies and in clinical pharmacokinetic studies.

Purpose of this study was to develop a stability-indicating RP-HPLC method for routine analysis of Paracetamol (PARA), Caffeine (CAF) and Ibuprofen (IBU) in their combined solid dosage forms. The new RP-HPLC method was validated as per ICH, FDA and USP guidelines with respect to accuracy, precision, specificity, linearity, solution stability, robustness, sensitivity and system suitability. The method was developed by using a binary gradient mode of phosphate buffer (pH 7.2) and acetonitrile at a flow rate of 1.3mL/min for 15 minutes over C-18 (ODS, 150 x 4.6 mm, 5µm) column at ambient temperature. Injection volume was 20µL for both standard and sample solutions and the eluents were monitored with UV detection at 230nm.Accuracy was determined by the recovery tests of the drugs and found to be within a range of 99.89% to 100.33%. Intraday and inter-day precisions were demonstrated by a relative standard deviation being far less than maximum allowable limit (2.0%, according to FDA). The method showed linear response with a correlation coefficient (r2) value of 0.999 for all three drugs. Forced degradation studies in acidic, basic, oxidation and reduction media were carried out to establish the stability indicating tolerance of this method. Specificity was shown by the separation of drugs with high degree of resolution between them and absence of any interference from the excipients or degradation products. This method was successfully applied to assay the drugs in tablets and capsules. Hence this newly developed method can be considered suitable and reliable for the routine analysis of PARA, CAF and IBU in their solid dosage forms.

A novel, simple, precise, accurate and reproducible RP-HPLC method was developed and validated for simultaneous estimation of paracetamol, tramadol and dicyclomine in bulk and pharmaceutical formulations. Separation of paracetamol, tramadol and dicyclomine was successfully achieved on a Inertsil ODS C18 (250mm x 4.6mm x 5 µm). The mobile consisted of ammonium acetate buffer (pH 4.5): methanol (80:20 v/v) at a flow rate of 1.0 mL/min. The detection was performed at 271 nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision and robustness. The response was found to be linear in the concentration range of 500 µg/mL to1500 µg/mL for paracetamol; 50µg/mL to150 µg/mL for tramadol; 10 µg/mL to 30 µg/mL for dicyclomine. The LOD and LOQ for paracetamol were found to be 2.712 µg/mL and 9.042 µg/mL, respectively. The LOD and LOQ for tramadol was 0.9009 µg/mL and 3.003 µg/mL, respectively and for dicyclomine it was 0.380 µg/mL and 1.265 µg/mL, respectively.  The percentage recovery for paracetamol, tramadol, and dicyclomine were found to be 99.00%, 100.00% and 99.00%, respectively. The excellent percentage recovery values indicate the high accuracy of the proposed method. The method specifically determines the analytes in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, Specificity and Robustness.

A simple accurate, precise and reproducible spectrophotometric method has been developed and validated for the simultaneous estimation of Paracetamol and Dicyclomine hydrochloride in combined tablet dosage form by Q-Absorbance ratio method. Q-Absorbance ratio method involves two wavelengths the iso-absorptive point and  λmax of paracetmol i.e. 231.5 nm and 257 nm respectively in 6 : 4 ratio methanol: 0.1 N NaOH mixture.  The linearity was detected in the range of 2-12 µg/ml (R2 = 0.9997) for Paracetamol and 10-35 µg/ml (R2 = 0.9989) for Dicyclomine Hydrochloride. The accuracy existed between 98-102% and the %RSD was less than 2%. The developed method was validated for linearity, accuracy and precision as per ICH guidelines.

Most of the synthetic drugs which induce side effect during overdose. The natural compounds are playing important role to reducing side effects of the synthetic drugs and also increase the immunity of recipients. The objective of the present study is to investigate the compatibility between Paracetamol as a synthetic compound with Spirulina as a natural compound.  The Paracetamol and Spirulina mixture were prepared in different ratio 1:1 (w/w) (Paracetamol: Spirulina), 1:2 (w/w) (Paracetamol: Spirulina) and 2: 1 (w/w) (Paracetamol: Spirulina). These samples were stored at different temperature (5 ˚C, 15 ˚ C, 30 ˚ C and 40 ˚ C) for one month. For every week samples were taken in the mixtures and the quantification of Paracetamol by using reversed phase liquid chromatography and estimation of chlorophyll A, B, total chlorophyll and total carotenoids in the mixture by using UV spectrophotometer. There was no significant loss of Paracetamol, chlorophyll, and carotenoids in their mixture. Both Paracetamol and Spirulina were stable under different temperature. Therefore it conclude that Paracetamol and Spirulina were compatible when mixed in a ratio of 1:1(w/w), 1:2 (w/w) and 2:1 w/w) 

There is a vast interest in the scientific community and drug industry to exploit various mucosal routes of delivering drugs, which are poorly absorbed after oral administration. Human rectum remains to be a relatively unexplored route of drug delivery despite its potential as a non- invasive route of drug administration. The presence of dense network of blood vessels has made the rectum an excellent route of drug delivery for both systemic and local effect. The present investigation was aimed to evaluating the possibility of using different surfactant i.e. Span 60 and 80, Tween 60 and 80 on the release rate of formulation for the development of rectal drug delivery system of paracetamol, an NSAIDs, to minimize the gastric irritation of the drug upon oral administration. Suppositories were formulated by fusion method & evaluated for their physicochemical characterization followed by in vitro evaluation through spectrophotometrically. Suppositories containing PEG 4000 with Tween 80 showed a better permeation of drug with faster dissolution rate in vitro than other formulations. The formulations were designed to overcome the risk of upper gastrointestinal complications such as stomach bleeding, and may cause kidney or liver damage. Suppositories are dosage forms for use in the unavoidable circumstances such as comatose, nauseous or vomiting.