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Table 7 Results of robustness for change in chromatographic parameters

From: Stability-indicating RP-HPLC method development and validation for simultaneous estimation of telmisartan and rosuvastatin calcium in bulk and in tablet dosage form

Modification in chromatographic conditions Retention time (min) Plate count Tailing factor % RSD Reso Retention time from sample
TLS RST TLS RST TLS RST TLS RST TLS RST
As per method 2.553 4.505 2917 8288 1.44 1.23 1.67 1.52 9.40 2.548 4.493
Flow rate − 0.1 mL/min 2.974 4.919 2804 8564 1.41 1.24 0.46 0.76 8.55 2.856 4.974
Flow rate + 0.1 mL/min 2.326 4.075 2746 7911 1.38 1.22 0.54 0.65 9.11 2.322 4.076
Organic phase − 10% 2.737 5.299 3226 8411 1.50 1.25 0.59 1.06 11.41 2.599 5.352
Organic phase + 10% 2.096 3.944 2986 6733 1.41 1.22 0.73 0.85 10.15 2.057 3.915
Buffer phase − 10% 2.095 4.047 2536 7191 1.48 1.22 0.51 0.58 10.93 2.108 4.000
Buffer phase + 10% 2.722 5.219 3070 9911 1.40 1.19 0.54 0.70 11.65 2.575 5.313
pH of buffer − 0.2 2.041 4.435 2762 8118 1.30 1.20 0.27 1.19 12.86 2.095 4.397
pH of buffer + 0.2 2.850 4.352 2630 7622 1.52 1.24 1.00 0.74 6.73 2.686 4.400
Quantity of PDP − 10% 2.376 4.632 2764 7875 1.53 1.22 0.32 0.66 11.16 2.340 4.593
Quantity of PDP + 10% 2.384 4.588 3038 6916 1.47 1.24 0.62 0.52 10.05 2.468 4.531
Quantity of OSASS − 10% 2.370 4.432 2961 7251 1.46 1.24 1.15 0.83 10.01 2.356 4.417
Quantity of OSASS + 10% 2.456 4.421 2879 7066 1.43 1.20 0.50 0.89 9.46 2.487 4.505
Acceptance criteria > 2000 NMT 2.0 ≤ 2.0 NLT 2.0 Similar to standard
  1. Reso. = USP resolution between telmisartan and rosuvastatin peak