Simultaneous Estimation Of Mometasone Furoate And Formoterol Fumarate By Hplc Method In Rotacaps

Objective: To develop and validate a simple and sensitive RP-HPLC method for the simultaneous determination of mometasone furoate (MOM) and formoterol fumarate (FOR) in pharmaceutical dosage forms. Methods: In RP-HPLC method, chromatographic separation was achieved using a mixture of a solvent system consisting of methanol–water (pH 3.5) in the ratio of 85:15 % v/v at a flow rate of 1 ml/min and detection was carried out at 225 nm. Results: The run time for the simultaneous estimation of drugs for the proposed method was 10 min as drugs eluted at 5.217 min (MOM) and 8.650 min (FOR). The linearity was found in the range of 33.33-299.97 μg/ml and 1-9 μg/ml for MOM and FOR, respectively. The values of limit of detection and limit of quantification were 3.634, 0.266 µg/ml and 11.014, 0.807 µg/ml, which indicates the sensitivity of the method for the estimation of MOM and FOR, respectively. The results of recovery studies for both the drugs were within the range i.e. 98.87-101.48 % which indicates the accuracy of the method. Relative standard deviation obtained from repeatability and reproducibility studies were less than 2% indicates the precision of the method. The proposed method was validated according to ICH guidelines. Conclusion: The proposed RP-HPLC method was found to be sensitive and precise because of the low LOD, LOQ and % RSD values (<2). The proposed work does not require acetonitrile and ion pairing reagent as compared to the reported methods. Therefore, method can be used preferably for routine analysis due to its simplicity and economic advantages.

Formulation and in vitro evaluation of berberine containing liposome optimized by 32 full factorial designs.

The present study demonstrates the application of 32 full factorial design for optimization of berberine loaded liposome for oral administration. Thin film hydration method was used to prepare liposome and optimization was done by 32 full factorial designs combined with desirability function. Nine formulations were prepared by using different drug : lipid and soyphosphatidylcholine : cholesterol (SPC:CHOL) ratios and evaluated for entrapment efficiency and vesicle size. The statistical validity of model was done by analysis of variance (ANOVA). Response surface graph and contour plots were used to understand the effect of variables on responses. The optimized formulation with 0.782 desirability value was prepared and evaluated for responses. The results of entrapment efficiency and vesicle size were found to be very close with the predicted values. In addition, an optimized formulation was also characterized for zeta potential, in vitro drug release and morphology. The formulation was found to be spherical shape with an average diameter of 0.823 nm and -1.93 mV zeta potential and also shows sustained release pattern. These results support the fact that 32 full factorial designs with desirability function could be effectively used in optimization of berberine loaded liposome.

Epidemiological and clinical profile of irritable bowel syndrome in India: report of the Indian Society of Gastroenterology Task Force.

AIMS: To study the profile of irritable bowel syndrome (IBS), and the frequency of such symptoms among the general population, in India. METHODS: In this prospective, multi-center study, data were obtained from 2785 patients with chronic lower gastrointestinal symptoms (complainants) with no alarm feature and negative investigations for organic causes visiting physicians at 30 centers, and from 4500 community subjects (non-complainants), using separate questionnaires. RESULTS: Most complainants were middle-aged (mean age 39.4 years) and male (1891; 68%). The common symptoms were: abdominal pain or discomfort (1958; 70%), abdominal fullness (1951; 70%); subjective feeling of constipation (1404 of 2656; 53%), or diarrhea (1252 of 2656, 47%), incomplete evacuation (2134; 77%), mucus with stools (1506; 54%), straining at stools (1271; 46%), epigastric pain (1364; 49%) and milk intolerance (906; 32%). Median stool frequency was similar in patients who felt they had constipation or those who felt they had diarrhea. Information to subtype symptoms using standard criteria was available in 1301 patients; of these, 507 (39%) had constipation-predominant IBS ( 3 <or= stools/week), 50 (4%) had diarrhea-predominant IBS (>3 stools/day) and 744 (57%) had indeterminate symptoms. Among non-complainants, most subjects reported daily defecation frequency of one (2520 [56%]) or two (1535 [34%]). Among non-complainants, 567 (12.6%) reported abdominal pain, 503 (11%) irregular bowel, 1030 (23%) incomplete evacuation, 167 (4%) mucus and 846 (18%) straining at stools; a combination of abdominal pain or discomfort relieved by defecation, and incomplete evacuation was present in 189/4500 (4.2%) community subjects. CONCLUSIONS: Most patients with IBS in India are middle-aged men, and have a sense of incomplete evacuation and mucus with stools. Abdominal pain or discomfort is frequent but not universal. Importantly, stool frequency was similar irrespective of whether the patients felt having constipation or diarrhea. Most (90%) non-complainant subjects had 1 or 2 stools per day; symptoms complex suggestive of IBS was present in 4.2% of community subjects.

Protein-c deficiency presenting with subacute intestinal obstruction due to mesenteric vein thrombosis.

We describe a patient with protein C deficiency who presented with subacute intestinal obstruction due to ischaemic small bowel stricture. The patient also had left sided ileofemoral thrombosis. Venous thrombosis at unusual sites especially if associated with deep vein thrombosis of lower limb warrants a thorough screen for underlying thrombophilia. This, however, is a rare cause for ischaemic small bowel stricture.

Should one vaccinate patients with chronic liver disease for hepatitis A virus in India?

BACKGROUND: Hepatitis A virus (HAV) vaccination is recommended worldwide for patients with chronic liver disease to prevent decompensation due to superinfection with HAV. India being endemic for HAV, the prevalence of pre-existing antibodies against HAV due to subclinical exposure to the virus in childhood among patients with chronic liver disease may be high and, therefore, vaccination may not be needed. However, little data are available on the prevalence of HAV antibody among patients with chronic liver disease in India. METHODS: All patients with chronic liver disease seen at Gastroenterology Center, Army Hospital R and R, New Delhi during the year 2002 and diagnosed to have either chronic liver disease were tested for the presence of IgG anti-HAV antibody in their sera (using a commercial ELISA kit). All patients with acute exacerbation or rapid deterioration of a preexisting chronic liver disease were separately studied for presence of IgM anti-HAV. In addition, a matched number of patients who attended the center due to diseases other than liver disease were also studied as controls. RESULTS: One hundred and eighty seven patients of chronic liver disease and 89 controls were studied. Mean age of these two groups was 38.6 and 42.1 years and 153 (81.8%) and 78 (87.6%) of them were males respectively. Etiology of chronic liver disease was HBV infection in 91(48.7%), HCV infection in 62 (33.2%), autoimmune chronic hepatitis in 3 (1.6%), PBC in seven (3.7%) and cryptogenic 24 (12.8%). Of these 179 (95.7%) patients tested positive for IgG anti-HAV. A total of 37 hospitalisations in 29 patients were noted during the study period due to acute exacerbation of pre-existing chronic liver disease. None of these were positive for IgM anti-HAV, while 28 were positive for IgG anti-HAV. Among the controls, 87 controls (94.6%) were positive IgG anti-HAV. The prevalence of anti-HAV positivity was similar among patients with various etiologies. CONCLUSION: Vaccination against HAV is not routinely required among patients with chronic liver disease in India as there is a very high prevalence of pre-existing antibodies in these patients. HAV superinfection as a cause of acute exacerbation of chronic liver disease was not seen in this.

Reversible segmental portal hypertension--an unusual presentation of abdominal tuberculosis in a renal transplant recipient.

Infections are the commonest cause of morbidity and mortality in renal transplant recipients. In India, tuberculosis is a one such common infection in these patients and presents with protean manifestations. We report here a case of pyrexia of unknown origin (PUO) and segmental portal hypertension in a renal transplant recipient. Search for the cause of portal hypertension revealed abdominal tubercular lymphadenitis. Treatment with anti-tubercular therapy caused regression of segmental portal hypertension.

Hepatopulmonary syndrome: prevalence and clinical profile.

BACKGROUND: The hepatopulmonary syndrome (HPS) is defined as a triad of liver dysfunction, intrapulmonary vascular dilatations (IPVD) and arterial hypoxemia. There is paucity of Indian studies regarding the prevalence of IPVD and arterial hypoxemia particularly amongst patients with non-cirrhotic portal fibrosis (NCPF) and extrahepatic portal vein obstruction (EHPVO), where liver dysfunction is not a feature. METHODS: All patients with portal hypertension and esophageal varices seen at a tertiary care hospital during 1995-98 were studied. Ultrasonography of abdomen, contrast-enhanced echocardiography (CEE), arterial blood gas analysis and assessment of alveolar-arterial oxygen gradient were done. RESULTS: Of 138 patients with portal hypertension seen during the study period, 88 fulfilled the inclusion and exclusion criteria. These included 63 with cirrhosis, 15 with NCPF and 10 with EHPVO. CEE showed IPVD in 17 (27%) patients with cirrhosis, of which 11 (17.5%) fulfilled the criteria for HPS. IPVD were also noted in 4 (26.6%) cases of NCPF and 3 (30%) of EHPVO, though only 2 (13.3%) and 1 (10%) respectively had elevated alveolar-arterial gradient and liver dysfunction in addition. Age and sex distribution and duration of symptoms were not different in patients with HPS. Patients with HPS had higher incidence of dyspnea, platypnea, clubbing and spider nevi. CONCLUSIONS: Hepatopulmonary syndrome is present in 17.5% of cirrhotics, 13.3% of patients with NCPF and 10% with EHPVO. Patients with HPS had significantly higher incidence of dyspnea, platypnea, clubbing and spider nevi.

Methaemoglobinaemia in areas with high nitrate concentration in drinking water.

BACKGROUND: An epidemiological investigation was undertaken in all age groups to assess the prevalence of methaemoglobinaemia in areas with high nitrate concentration in drinking water. METHODS: Five areas were selected with an average nitrate concentration (as nitrate) of 26, 45, 95, 222 and 459 mg nitrate ions/litre in drinking water. These areas were visited and the house schedule (containing name, age, sex and weight of the family members) prepared in accordance with the statistically designed protocol. In all, 178 persons, matched for age and weight, were selected and arranged in five age groups. They constituted 10% of the total population of each of these areas. A detailed history of the selected population was taken, medical examination conducted and blood samples taken to ascertain the level of methaemoglobin. The collected data were subjected to statistical analysis to ascertain a relationship between nitrate concentration and methaemoglobinaemia. RESULTS: High nitrate concentrations cause severe methaemoglobinaemia (7%-27% of Hb) in all age groups, especially in the age group of less than 1 year and above 18 years. The lower levels of methaemoglobin in the age group of 1-18 years is probably due to better reserve of cytochrome b5 reductase activity and its adaptation to increasing nitrate concentration in water to compensate for methaemoglobinaemia in this age group. CONCLUSION: We conclude that high nitrate ingestion causes methaemoglobinaemia in all age groups. Cytochrome b5 reductase activity and its adaptation with increasing water nitrate ingestion plays a role in compensating for the methaemoglobinaemia.

Combined percutaneous-endoscopic approach for biliary endoprosthesis placement.

A nonoperative method of palliation was used in four patients with malignant obstructive jaundice in whom biliary endoprosthesis could not be placed endoscopically. A guide wire was manipulated through the lesion by a percutaneous transhepatic route and retrieved from the duodenum through an endoscope. A 10 Fr stent was then passed through the endoscope over the guide wire across the stricture. The procedure was successful in all four patients, with no complication.

Caroli's disease: a central dot means a lot.

We present here a patient of congenital non-obstructive focal dilatation of intrahepatic biliary radicles (Caroli's disease). The peculiar configuration of dilated intrahepatic biliary channels with central portal vein radicles was picked up sonologically as the 'central dot' sign. Awareness of this sign allows an accurate diagnosis without resorting to more invasive and expensive investigations.

Reversal of clinical and dental fluorosis.

A large number of Indians are forced to consume fluoride contaminated water. Toxic effects of chronic fluoride ingestion are hitherto considered irreversible. In this study 20 children were selected from an area consuming water containing 4.5 ppm of fluoride (Group A) and a second sample of 20 children from another area consuming water containing 8.5 ppm of fluoride (Group B). All the children were in an age group of 3 to 12 years and weighed 12 to 25 kg. Both samples were graded for clinical, radiological and dental fluorosis. All grades of manifestations were observed. These children were given ascorbic acid (500 mg), calcium (250 mg) and vitamin D3 (800 IU) daily. Follow up revealed reversal of clinical and dental fluorosis after 44 days. Improvement in the Group B sample was slower than Group A. Dosage of ascorbic acid was increased to 750 mg per day, keeping the dosages of other drugs unchanged to Group B children. After 15 days of the revised therapy a marked improvement was noticed in clinical and dental fluorosis in this sample also.