China Valsartan Hydrochlorothiazide Market

A  simple,  robust,  precise  HPLC  method  was  developed  and  the
method  has  been  validated  for  the  estimation  of  valsartan  and
nebivolol  simultaneously  in  its  combined  dosage  forms  as  well  as
individual formulations. Both the compounds are well resolved in a
isocratic  method  by  using  the  mobile  phase  composition  of
acetonitrile: methanol: pH4.0 0.02M Potassium hydrogen phosphate
buffer in the ratio of 50:20:30 v/v at a flow rate of 1.0mL/min using a
C-18 column. The detection was carried out at 210nm.. The retention
time  of  Nebivolol  and  Valsartan  were  2.5  min  and  4.3  min
respectively.  The  developed  method  was  validated  for  specificity,
linearity,  precision,  accuracy,  limit  of  detection  (LOD),  limit  of
quantification (LOQ) and robustness as per ICH guidelines. Linearity
for Nebivolol and Valsartan were found in the range of 48-112 µg/ml
and  3.0-7.0  µg/ml,  respectively.  The  percentage  recoveries  for
Nebivolol  and  Valsartan  ranged  from  98.9-100.8  %  and  98.9-101.1
%,  respectively.  The  proposed  method  could  be  used  for  routine
analysis of Nebivolol and Valsartan in their combined dosage forms

Objectives: Formulation of triplet combined solid dosage film coated
tablet  containing  amlodipine  besylate  (equivalent  to  5  mg
amlodipine), hydrochlorothiazide (12.5 mg) and losartan potassium
(50 mg) for the treatment of severe hypertension. Development and
validated of a simple, fast, precise, selective and accurate HPLC
method  for  the  simultaneous  determination  of  amlodipine  besylate,
hydrochlorothiazide and losartan potassium in the tablets.
Methods:  The  formulation  of  the  tablets  was  carried  out  as  per
standard  protocols. The  various  steps  involve  in  formulation  were
dispensing  of  raw  materials,  sieving,  preparation  of  granulating
solvent,  mixing,  granulation,  drying  (In  FBD),  lubrication,
compression and coating. The separation of these three drugs was
achieved on a Sun Shell C8 column (150 mm x 4.6 mm, 2.6 μm) with
phosphate  buffer-acetonitrile  (70:30%  v/v)  as  mobile  phase  at  1.0
mL/min flow rate and 230 nm detection.
Results  and  Conclusion: The  physical  parameters  of  tablets  were
satisfactory  with  average  weight  deviation  from  3.23  to  3.29%,
friability 0.04%, disintegration time 8.3 minutes, average hardness
85.43N and thickness from 3.92 to 4.01 mm. The assay was found to
be 99.89%, 99.99% and 99.97% of amlodipine, hydrochlorothiazide
and losartan potassium, respectively. The dissolution was found to be
98.8 to 99.70%, 97.85 to 98.95% and 97.98 to 99.99% of amlodipine,
hydrochlorothiazide  and  losartan  potassium,  respectively.  The
uniformity of content was 99.85 to 99.99% and 99.60 to 99.99% of
amlodipine  and  hydrochlorothiazide,  respectively.  The  retention
times  observed  were  to  be  7.338,  2.097  and  10.675  minutes  for
amlodipine  besylate,  hydrochlorothiazide  and  losartan  potassium,
respectively.  The  method  was  statistically  validated  for  linearity,
recovery,  limit  of  detection,  limit  of  quantification,  accuracy, precision,  robustness,  stability  of  drugs  in  pure  form  and  in
presence of matrices and forced degradation study. The method
was successfully applied for analysis of combined dose tablet.